Phase III Results Showed omalizumab Significantly Reduced Disease Severity in Patients with a Chronic form of Hives who Failed Standard Therapy
SOUTH SAN FRANCISCO, Calif. -- February 24, 2013 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced results from a Phase III trial, ASTERIA II, which demonstrated that omalizumab met its primary endpoint in patients with moderate to severe chronic idiopathic urticaria (CIU)
(PressZoom) - SOUTH SAN FRANCISCO, Calif. -- February 24, 2013 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced results from a Phase III trial, ASTERIA II, which demonstrated that omalizumab met its primary endpoint in patients with moderate to severe chronic idiopathic urticaria (CIU), who remained symptomatic despite treatment with approved H1 antihistamine doses1. The data were published today in the New England Journal of Medicine and will be presented tomorrow at the American Academy of Allergy, Asthma and Immunology (AAAAI) Annual Meeting in San Antonio, TX.
CIU, also referred to as chronic spontaneous urticaria (CSU) outside the United States, is a skin condition characterized by red, swollen, itchy hives on the skin2,3 and is diagnosed when hives spontaneously present and reoccur for more than six weeks2. Angioedema, or swelling of the deep layers of skin, is common in patients with CIU4,5. At any given time, the prevalence of CIU is approximately 0.5 percent to 1 percent worldwide4,5. Currently, H1 antihistamines are the only approved therapy for patients suffering from CIU.
"We are pleased with the results of the ASTERIA II study, as people with chronic idiopathic urticaria unresponsive to H1 antihistamines need new treatment options," said Hal Barron, M.D., chief medical officer and head of Global Product Development. "We look forward to sharing the results of two additional Phase III omalizumab CIU studies at upcoming medical meetings this year."
Genentech plans to file a supplemental biologics license application (sBLA) with the U.S. Food and Drug Administration (FDA) for omalizumab in CIU later this year. The ASTERIA II data are the first Phase III results to be presented from the omalizumab clinical trial program in CIU, which also includes two additional Phase III studies (GLACIAL and ASTERIA I) investigating the efficacy and safety profile of omalizumab over 24-week treatment duration.
Study Results The primary endpoint was measured using a 21-point scale known as a weekly Itch Severity Score (ISS)1. Patients used an electronic diary to report their daily itch severity (0=none, 1=mild, 2=moderate, and 3=severe), with potential weekly scores ranging from 0-211. Three dose groups were chosen and compared to a placebo group. The study met its primary endpoint in two of the three dose groups studied, showing that omalizumab administered every four weeks led to significant improvement in the mean weekly ISS from baseline (approximately 14 in all treatment groups) at Week 12.
The improvements were 8.1 to 9.8 in two of the dose groups, respectively compared to a 5.1 improvement in patients on placebo. One of the dose groups studied did not demonstrate statistical significance compared to placebo for the primary endpoint. The incidence and severity of adverse events (AEs) was similar across treatment groups1.
All eight pre-specified secondary endpoints in the ASTERIA II trial were met for the two dose groups that met the primary endpoint, except for one dose group that did not show a significant difference from placebo in the proportion of angioedema-free days from Week 4 to Week 12 of therapy1. Patient response, as measured by the median time to Minimally Important Difference (MID) in itch severity score, a secondary endpoint, occurred at week one with omalizumab compared with four weeks in the placebo group1.
Nine patients experienced serious adverse events (SAEs): two patients in the placebo group reported SAEs of pneumonia and hemorrhoids; in the three omalizumab dose groups, seven patients reported SAEs of angioedema (two), urticaria, idiopathic urticaria (two), melanoma in situ (onset stage of skin cancer), nephrolithiasis (kidney stones), tonsillectomy, and melena (black blood in stool). No SAEs were suspected to be caused by the study drug or led to withdrawal from treatment1. No deaths were reported during the study1.
About ASTERIA II ASTERIA II was a Phase III, global, multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety profile of omalizumab compared with placebo in 323 patients 12 to 75 years of age with moderate to severe CIU who were receiving H1 antihistamine therapy at approved doses. Patients were randomized to three omalizumab dose groups or placebo, given every four weeks, for a total of three doses within a 12-week treatment period1.
In addition to the primary endpoint, the study had eight pre-specified secondary endpoints: Change from baseline in weekly urticaria activity score (UAS7) at Week 12; Change from baseline in weekly number of hives score at Week 12; Time to MID (MID=5) response in weekly itch severity score by Week 12; Proportion of patients with UAS7 ≤ 6 at Week 12; Change from baseline in overall dermatology life quality index (DLQI) at Week 12; Proportion of angioedema-free days from Week 4 to Week 12; Proportion of patients with MID response in weekly itch at Week 12; Change from baseline in size of largest hives score at Week 12.
Omalizumab is jointly developed by Genentech under an agreement with Novartis Pharma AG and is co-marketed in the United States with Novartis Pharmaceuticals Corporation.
About XOLAIR XOLAIR is not indicated for Chronic Idiopathic Urticaria.
XOLAIR® (omalizumab) for subcutaneous use is an injectable, prescription medicine for patients 12 years of age and older. It is for patients with moderate to severe persistent allergic asthma caused by year-round allergens in the air. A skin or blood test is done to see if you have allergic asthma. XOLAIR is for patients who are not controlled by asthma medicines called inhaled steroids.
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.
Important Limitations of Use
•XOLAIR has not been proven to work in 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.
IMPORTANT SAFETY INFORMATION IN MODERATE TO SEVERE ALLERGIC ASTHMA
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.
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 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.
Please visit http://www.xolair.com for the full Prescribing Information, including Boxed WARNINGS and Medication Guide for additional important safety information.
About Genentech Access Solutions Genentech is committed to people having access to our medicines. Genentech Access Solutions is a team of more than 350 Genentech employees who help those who need our medicines. Our knowledgeable and experienced Specialists can help patients and medical practices navigate the access and reimbursement process and provide assistance to eligible patients in the United States who do not have insurance coverage or who cannot afford their out-of-pocket co-pay costs. For more information, please visit http://www.GenentechAccessSolutions.com.
About Genentech Founded more than 30 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.
References 1 Maurer M, Rosén K, Hsieh HJ, et al. Omalizumab for the treatment of chronic idiopathic or spontaneous urticaria. NEJM 2013; DOI: 10.1056/NEJMoa1215372 2 Asthma and Allergy Foundation of America (AAFA) website. "Chronic Urticaria (Hives)." http://www.aafa.org/display.cfm?id=9&sub=23&cont=328. Accessed November 14, 2012. 3 American Academy of Allergy Asthma & Immunology (AAAAI) website. "Skin Allergy Overview." http://www.aaaai.org/conditions-and-treatments/allergies/skin-allergy.aspx. Accessed November 14, 2012. 4 Maurer M, Weller K, Bindslev-Jensen C, et al. Unmet clinical needs in chronic spontaneous urticaria. A GA2LEN task force report. Allergy 2011; 66: 317-330. 5 Bernstein J, Moellman J. Emerging concepts in the diagnosis and treatment of patients with undifferentiated angioedema. Int J Emerg Med 2012. 5: 39.
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