|By PR Newswire||
|February 24, 2013 01:18 PM EST||
EAST HANOVER, N.J., Feb. 24, 2013 /PRNewswire/ -- Late-breaking results from ASTERIA II, a Phase III placebo-controlled study, showed positive results in patients with moderate to severe chronic idiopathic urticaria (CIU), referred to as chronic spontaneous urticaria (CSU) outside the United States, who remained symptomatic despite treatment with approved antihistamine doses. The data were published today in the New England Journal of Medicine and will be presented tomorrow at the American Academy of Allergy, Asthma & Immunology (AAAAI) annual meeting in San Antonio, Texas. Omalizumab is not indicated for CIU.
The primary endpoint was measured using a 21-point scale known as a weekly Itch Severity Score (ISS). The study met its primary endpoint, showing that omalizumab given at doses of 150 mg and 300 mg every four weeks led to significant improvement from baseline at Week 12 in the mean weekly ISS from baseline (approximately 14 in all treatment groups) by 8.1 (p=0.001) and 9.8 (p<0.001), respectively, compared to a 5.1 improvement in patients on placebo. The omalizumab 75 mg dose group did not demonstrate statistical significance compared to placebo for the primary endpoint. All eight pre-specified secondary endpoints in the ASTERIA II trial were met for the 150 mg and 300 mg doses, except for the 150 mg dose that did not show a significant difference from placebo in the proportion of angioedema-free days from Week 4 to Week 12 of therapy.
CIU is a distressing skin condition characterized by red, swollen, itchy and sometimes painful hives on the skin, spontaneously presenting and reoccurring for more than six weeks. At any given time, the prevalence of CIU is 0.5% to 1% worldwide. While antihistamines are used first to treat CIU, more than 50% of patients are unable to achieve symptom relief with approved doses.
"These results indicate that omalizumab could potentially be an important addition in the treatment of chronic idiopathic urticaria, a disease that can have a significant impact on patients and can be challenging to manage," said Tim Wright, Global Head of Development, Novartis Pharmaceuticals. "We are committed to helping patients with this disease and look forward to receiving further results from ongoing longer-term clinical trials."
ASTERIA II is the first Phase III data to be presented from a clinical trial program in CIU, which also includes two additional studies investigating the efficacy and safety profile of omalizumab over 24 weeks treatment duration. Novartis regulatory submissions are on track for 2013.
"These results are encouraging news for appropriate patients whose CIU is unresponsive to antihistamines," said study co-lead investigator, Thomas Casale, MD, Chief of Allergy & Immunology at Creighton University Medical Center and Professor of Medicine and Medical Microbiology at Creighton University, Omaha, NE. "New and effective therapeutic strategies for CIU are necessary as treatment options are limited for these patients."
ASTERIA II was a global, multi-center, randomized, double-blind study that evaluated the efficacy and safety profile of omalizumab compared to placebo and involved 323 patients aged between 12 and 75 with a diagnosis of moderate to severe CIU for at least six months. Patients were required to have the presence of itch and hives for at least eight consecutive weeks at any time prior to enrollment despite use of approved doses of H1 antihistamine treatment. Patients were randomized to omalizumab 75 mg, 150 mg or 300 mg or placebo, given subcutaneously every four weeks, for a total of three doses within a 12-week treatment period, with a 16-week follow-up period. Patients continued to receive stable doses of their pre-randomization H1 antihistamine. For the primary endpoint, the omalizumab 75 mg dose group did not demonstrate statistical significance compared to placebo. However, omalizumab 150 mg and 300 mg dose groups met the pre-specified primary endpoint and all eight pre-specified secondary endpoints in the ASTERIA II trial, except for the 150 mg dose that did not show a significant difference from placebo in the proportion of angioedema-free days from Week 4 to Week 12 of therapy. Patient response, as measured by the median time to Minimally Important Difference (MID) in itch severity score, a secondary endpoint, occurred at Week 1 (300 mg dose) and Week 2 (150 mg dose), compared to Week 4 in the placebo group.
The incidence and severity of adverse events (AEs) was similar across treatment groups. The most frequently reported treatment-emergent adverse events in patients taking omalizumab (>10% in any omalizumab treatment arm) in the study (including treatment period and follow-up period) were nasopharyngitis (nasal and throat infection or common cold), idiopathic urticaria (hives and itching, trigger unknown) and headache. Five (6.3%) patients experienced serious adverse events (SAEs) in the omalizumab 300 mg dose group, compared to two (2.5%) in the placebo group. In the 150 mg and 75 mg dose groups, one patient experienced SAEs in each group (1.1% and 1.3%, respectively). No deaths were reported during this study.
Omalizumab is not indicated for CIU.
Omalizumab is a biologic therapy unique in targeting immunoglobulin E (IgE). Research is ongoing to understand the mechanism of action of omalizumab in CIU and to investigate its potential impact on the drivers of CIU. Omalizumab is approved for the treatment of moderate to severe allergic asthma under the brand-name Xolair® in more than 90 countries, including the US since 2003 and the EU since 2005. In the US, Xolair is indicated for appropriate people who are 12 years of age and older who have moderate to severe persistent allergic asthma caused by year-round allergens in the air and are uncontrolled on inhaled corticosteroids. Xolair helps reduce the number of asthma attacks in people with allergic asthma who still have asthma symptoms even though they are taking inhaled steroids. Xolair should not be used to treat other allergic conditions. Xolair is not a rescue medicine and should not be used to treat sudden asthma attacks. Xolair should not be used in children under 12 years of age.
Omalizumab is being jointly developed by Novartis and Genentech. In the US, Xolair® (omalizumab) for subcutaneous use in appropriate allergic asthma patients is co-promoted by Novartis Pharmaceuticals Corporation and Genentech.
About Xolair® (omalizumab) for subcutaneous use
Important Safety Information: Appropriate Moderate-Severe Allergic Asthma Patients
Xolair should always be injected in a doctor's office. Patients should read the Medication Guide before starting Xolair treatment and before each and every treatment.
A severe allergic reaction called anaphylaxis has happened in some patients after they received Xolair. Anaphylaxis is a life-threatening condition and can lead to death. Patients must seek emergency medical treatment right away if symptoms occur.
Signs and symptoms of anaphylaxis include:
- wheezing, shortness of breath, cough, chest tightness, or trouble breathing
- low blood pressure, dizziness, fainting, rapid or weak heartbeat, anxiety, or feeling of "impending doom"
- flushing, itching, hives, or feeling warm
- swelling of the throat or tongue, throat tightness, hoarse voice, or trouble swallowing
Anaphylaxis from Xolair can happen:
- right after receiving a Xolair injection or hours later
- after any Xolair injection. Anaphylaxis has occurred after the first Xolair injection or after many Xolair injections.
A patient's healthcare provider should watch the patient for some time in the office for signs or symptoms of anaphylaxis after injecting Xolair. If patients have signs or symptoms of anaphylaxis, they must tell their healthcare provider right away.
Patients must not receive Xolair if they have ever had an allergic reaction to a Xolair injection. Patients should not use Xolair if they are allergic to any of its ingredients.
In clinical studies, a variety of cancer types, including breast, skin, prostate, and parotid (a type of salivary gland), were reported in more patients who received Xolair than in patients who did not receive Xolair.
Xolair is not a rescue medicine and should not be used to treat sudden asthma attacks.
Xolair is not a substitute for the medicines patients are already taking. Patients must not change or stop taking any of their other asthma medicines unless their doctor tells them to do so.
Some patients on Xolair may have an abnormal increase in eosinophils (a type of white blood cell) in the blood or tissues, sometimes causing an inflammation of blood vessels which can lead to rash, worsening of respiratory symptoms, heart trouble, and/or nerve pain and weakness.
Joint inflammation or pain, rash, fever, and swollen lymph nodes have been seen in some patients taking Xolair after the first or subsequent injections. Patients should talk to their doctor if they have experienced any of these signs and symptoms.
In allergic asthma studies, the most commonly seen side effects occurring more frequently in patients receiving Xolair than in patients who received placebo (an injection with no active medicine) were joint pain, pain (general), leg pain, tiredness (fatigue), dizziness, fracture, arm pain, itching, inflammation of the skin, and earache.
In allergic asthma studies, the most common side effects in patients, who either needed to stop Xolair or needed medical attention, were injection site reaction, viral infections, upper respiratory tract infection, sinusitis, headache, and sore throat. These side effects were seen at similar rates in Xolair-treated patients as in patients that did not receive Xolair.
There are other possible side effects with Xolair. Patients should talk to their doctor for more information and if they have any questions about their treatment.
Xolair has not been studied in pregnant women. Pregnant women exposed to Xolair are encouraged to enroll in the Xolair Pregnancy Exposure Registry. Patients can get more information by calling 1-866-4XOLAIR (1-866-496-5247) or by speaking with their doctor.
For the full Prescribing Information, including Boxed WARNINGS and Medication Guide for additional important safety information please log onto http://www.pharma.us.novartis.com/cs/www.pharma.us.novartis.com/product/pi/pdf/Xolair.pdf or contact Christine Cascio at 862-778-8026.
The foregoing release contains forward-looking statements that can be identified by terminology such as "to be," "will be," "to investigate," "potentially," "could," "committed," "look forward to," "on track," "potential," or similar expressions, or by express or implied discussions regarding potential new indications or labeling for omalizumab or regarding potential future revenues from omalizumab. You should not place undue reliance on these statements. Such forward-looking statements reflect the current views of management regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results with omalizumab to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that omalizumab will be approved for any additional indications or labeling in any market. Nor can there be any guarantee that omalizumab will achieve any particular levels of revenue in the future. In particular, management's expectations regarding omalizumab could be affected by, among other things, unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; unexpected regulatory actions or delays or government regulation generally; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; government, industry and general public pricing pressures; competition in general; unexpected manufacturing issues; the impact that the foregoing factors could have on the values attributed to the Novartis Group's assets and liabilities as recorded in the Group's consolidated balance sheet, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
Novartis Pharmaceuticals Corporation researches, develops, manufactures and markets innovative prescription drugs used to treat a number of diseases and conditions, including cardiovascular, dermatological, central nervous system, bone disease, cancer, organ transplantation, psychiatry, infectious disease and respiratory. The company's mission is to improve people's lives by pioneering novel healthcare solutions.
Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG, which provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care, cost-saving generic pharmaceuticals, preventive vaccines and diagnostic tools, over-the-counter and animal health products. Novartis is the only global company with leading positions in these areas. In 2012, the Group achieved net sales of USD 56.7 billion, while R&D throughout the Group amounted to approximately USD 9.3 billion (USD 9.1 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 128,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visit http://www.novartis.com.
Novartis is on Twitter. Sign up to follow @Novartis at http://twitter.com/novartis.
Novartis Media Relations
+1 212 830 2465 (direct)
+1 862 579 8456 (mobile)
Novartis Pharmaceuticals Corporation
+1 862 778 8026 (direct)
+1 862 926 7992 (mobile)
e-mail: [email protected]
SOURCE Novartis Pharmaceuticals Corporation
"At ROHA we develop an app called Catcha. It was developed after we spent a year meeting with, talking to, interacting with senior citizens watching them use their smartphones and talking to them about how they use their smartphones so we could get to know their smartphone behavior," explained Dave Woods, Chief Innovation Officer at ROHA, in this SYS-CON.tv interview at 19th Cloud Expo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 7, 2016 12:30 PM EST Reads: 597
SYS-CON Events has announced today that Roger Strukhoff has been named conference chair of Cloud Expo and @ThingsExpo 2017 New York. The 20th Cloud Expo and 7th @ThingsExpo will take place on June 6-8, 2017, at the Javits Center in New York City, NY. "The Internet of Things brings trillions of dollars of opportunity to developers and enterprise IT, no matter how you measure it," stated Roger Strukhoff. "More importantly, it leverages the power of devices and the Internet to enable us all to im...
Dec. 7, 2016 12:30 PM EST Reads: 702
Extracting business value from Internet of Things (IoT) data doesn’t happen overnight. There are several requirements that must be satisfied, including IoT device enablement, data analysis, real-time detection of complex events and automated orchestration of actions. Unfortunately, too many companies fall short in achieving their business goals by implementing incomplete solutions or not focusing on tangible use cases. In his general session at @ThingsExpo, Dave McCarthy, Director of Products...
Dec. 7, 2016 12:30 PM EST Reads: 831
We are always online. We access our data, our finances, work, and various services on the Internet. But we live in a congested world of information in which the roads were built two decades ago. The quest for better, faster Internet routing has been around for a decade, but nobody solved this problem. We’ve seen band-aid approaches like CDNs that attack a niche's slice of static content part of the Internet, but that’s it. It does not address the dynamic services-based Internet of today. It does...
Dec. 7, 2016 12:00 PM EST Reads: 1,110
The many IoT deployments around the world are busy integrating smart devices and sensors into their enterprise IT infrastructures. Yet all of this technology – and there are an amazing number of choices – is of no use without the software to gather, communicate, and analyze the new data flows. Without software, there is no IT. In this power panel at @ThingsExpo, moderated by Conference Chair Roger Strukhoff, Dave McCarthy, Director of Products at Bsquare Corporation; Alan Williamson, Principal...
Dec. 7, 2016 11:47 AM EST Reads: 195
"ReadyTalk is an audio and web video conferencing provider. We've really come to embrace WebRTC as the platform for our future of technology," explained Dan Cunningham, CTO of ReadyTalk, in this SYS-CON.tv interview at WebRTC Summit at 19th Cloud Expo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 7, 2016 11:30 AM EST Reads: 646
20th Cloud Expo, taking place June 6-8, 2017, at the Javits Center in New York City, NY, will feature technical sessions from a rock star conference faculty and the leading industry players in the world. Cloud computing is now being embraced by a majority of enterprises of all sizes. Yesterday's debate about public vs. private has transformed into the reality of hybrid cloud: a recent survey shows that 74% of enterprises have a hybrid cloud strategy.
Dec. 7, 2016 11:15 AM EST Reads: 2,283
IoT solutions exploit operational data generated by Internet-connected smart “things” for the purpose of gaining operational insight and producing “better outcomes” (for example, create new business models, eliminate unscheduled maintenance, etc.). The explosive proliferation of IoT solutions will result in an exponential growth in the volume of IoT data, precipitating significant Information Governance issues: who owns the IoT data, what are the rights/duties of IoT solutions adopters towards t...
Dec. 7, 2016 11:01 AM EST Reads: 168
WebRTC is the future of browser-to-browser communications, and continues to make inroads into the traditional, difficult, plug-in web communications world. The 6th WebRTC Summit continues our tradition of delivering the latest and greatest presentations within the world of WebRTC. Topics include voice calling, video chat, P2P file sharing, and use cases that have already leveraged the power and convenience of WebRTC.
Dec. 7, 2016 10:30 AM EST Reads: 1,703
Unsecured IoT devices were used to launch crippling DDOS attacks in October 2016, targeting services such as Twitter, Spotify, and GitHub. Subsequent testimony to Congress about potential attacks on office buildings, schools, and hospitals raised the possibility for the IoT to harm and even kill people. What should be done? Does the government need to intervene? This panel at @ThingExpo New York brings together leading IoT and security experts to discuss this very serious topic.
Dec. 7, 2016 10:00 AM EST Reads: 410
In his keynote at 18th Cloud Expo, Andrew Keys, Co-Founder of ConsenSys Enterprise, provided an overview of the evolution of the Internet and the Database and the future of their combination – the Blockchain. Andrew Keys is Co-Founder of ConsenSys Enterprise. He comes to ConsenSys Enterprise with capital markets, technology and entrepreneurial experience. Previously, he worked for UBS investment bank in equities analysis. Later, he was responsible for the creation and distribution of life sett...
Dec. 7, 2016 09:15 AM EST Reads: 7,243
Dec. 7, 2016 08:30 AM EST Reads: 1,868
Whether your IoT service is connecting cars, homes, appliances, wearable, cameras or other devices, one question hangs in the balance – how do you actually make money from this service? The ability to turn your IoT service into profit requires the ability to create a monetization strategy that is flexible, scalable and working for you in real-time. It must be a transparent, smoothly implemented strategy that all stakeholders – from customers to the board – will be able to understand and comprehe...
Dec. 7, 2016 08:15 AM EST Reads: 500
An IoT product’s log files speak volumes about what’s happening with your products in the field, pinpointing current and potential issues, and enabling you to predict failures and save millions of dollars in inventory. But until recently, no one knew how to listen. In his session at @ThingsExpo, Dan Gettens, Chief Research Officer at OnProcess, discussed recent research by Massachusetts Institute of Technology and OnProcess Technology, where MIT created a new, breakthrough analytics model for ...
Dec. 7, 2016 08:00 AM EST Reads: 462
DevOps is being widely accepted (if not fully adopted) as essential in enterprise IT. But as Enterprise DevOps gains maturity, expands scope, and increases velocity, the need for data-driven decisions across teams becomes more acute. DevOps teams in any modern business must wrangle the ‘digital exhaust’ from the delivery toolchain, "pervasive" and "cognitive" computing, APIs and services, mobile devices and applications, the Internet of Things, and now even blockchain. In this power panel at @...
Dec. 7, 2016 07:45 AM EST Reads: 858
More and more brands have jumped on the IoT bandwagon. We have an excess of wearables – activity trackers, smartwatches, smart glasses and sneakers, and more that track seemingly endless datapoints. However, most consumers have no idea what “IoT” means. Creating more wearables that track data shouldn't be the aim of brands; delivering meaningful, tangible relevance to their users should be. We're in a period in which the IoT pendulum is still swinging. Initially, it swung toward "smart for smar...
Dec. 7, 2016 07:30 AM EST Reads: 837
With major technology companies and startups seriously embracing IoT strategies, now is the perfect time to attend @ThingsExpo 2016 in New York. Learn what is going on, contribute to the discussions, and ensure that your enterprise is as "IoT-Ready" as it can be! Internet of @ThingsExpo, taking place June 6-8, 2017, at the Javits Center in New York City, New York, is co-located with 20th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry p...
Dec. 7, 2016 06:45 AM EST Reads: 2,002
"We build IoT infrastructure products - when you have to integrate different devices, different systems and cloud you have to build an application to do that but we eliminate the need to build an application. Our products can integrate any device, any system, any cloud regardless of protocol," explained Peter Jung, Chief Product Officer at Pulzze Systems, in this SYS-CON.tv interview at @ThingsExpo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 7, 2016 05:15 AM EST Reads: 1,081
Internet of @ThingsExpo has announced today that Chris Matthieu has been named tech chair of Internet of @ThingsExpo 2017 New York The 7th Internet of @ThingsExpo will take place on June 6-8, 2017, at the Javits Center in New York City, New York. Chris Matthieu is the co-founder and CTO of Octoblu, a revolutionary real-time IoT platform recently acquired by Citrix. Octoblu connects things, systems, people and clouds to a global mesh network allowing users to automate and control design flo...
Dec. 7, 2016 02:00 AM EST Reads: 672
In addition to all the benefits, IoT is also bringing new kind of customer experience challenges - cars that unlock themselves, thermostats turning houses into saunas and baby video monitors broadcasting over the internet. This list can only increase because while IoT services should be intuitive and simple to use, the delivery ecosystem is a myriad of potential problems as IoT explodes complexity. So finding a performance issue is like finding the proverbial needle in the haystack.
Dec. 7, 2016 01:45 AM EST Reads: 6,171