FDA Files Genentech's Supplemental Biologics License Application of Xolair® (omalizumab) for Chronic

FDA Files Genentech's Supplemental Biologics License Application of Xolair ® (omalizumab) for Chronic Idiopathic Urticaria (CIU)

  • CIU is a skin condition characterized by red, swollen, itchy hives
  • Currently, H1-antihistamines are the only approved therapy for patients suffering from CIU, also known as chronic spontaneous urticaria (CSU)
  • FDA Decision on sBLA expected during second quarter of 2014

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has accepted and filed the company's supplemental Biologics License Application (sBLA) for subcutaneous use of Xolair® (omalizumab) in people with Chronic Idiopathic Urticaria (CIU) who remained symptomatic despite treatment with H1-antihistamine therapy at approved doses. Xolair is jointly developed by Genentech and Novartis Pharma AG and is co-marketed in the United States with Novartis Pharmaceuticals Corporation. The FDA action date is second quarter of 2014.

CIU, also known as chronic spontaneous urticaria (CSU), is a skin condition characterized by red, swollen, itchy hives.1,3 It is diagnosed when hives spontaneously present without an identifiable cause and reoccur for more than six weeks.1 Some 30-50 percent of CIU patients also have angioedema, where swelling occurs under the skin instead of on the surface. The prevalence of CIU is approximately 0.5 to 1 percent of the worldwide population.2 Currently, H1-antihistamines are the only approved therapy for patients suffering from CIU.


"We are pleased that the FDA has filed our application for Xolair for chronic idiopathic urticaria," said Hal Barron, M.D., chief medical officer and head, Global Product Development. "We hope we can soon bring our medicine to people with this chronic form of hives."

Development Program

The sBLA was primarily based on two, global, multi-center, randomized, double-blind, placebo-controlled Phase III studies (ASTERIA I and ASTERIA II) in a total of 642 (319 and 323, respectively) patients with moderate-to-severe CIU who remained symptomatic despite treatment with H1-antihistamine therapy at approved doses. A third study (GLACIAL) was a global Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study in 336 patients to primarily evaluate the safety profile of Xolair as an add-on therapy in CIU patients who remained symptomatic despite other treatments with antihistamines.

About XOLAIR

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.

  • 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.

Report side effects to the FDA at (800) FDA-1088 or http://www.fda.gov/medwatch. Patients and caregivers may also report side effects to Genentech at (888) 835-2555.

Please visit http://www.xolair.com for the full Prescribing Information, including Boxed WARNINGS and Medication Guide for additional important safety information.

About Genentech

Founded more than 35 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 Asthma and Allergy Foundation of America (AAFA) website. "Chronic Urticaria (Hives)." http://www.aafa.org/display.cfm?id=9⊂=23&cont=328. Accessed August 6, 2013.

2 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.

3 American Academy of Allergy Asthma & Immunology (AAAAI) website. "Skin Allergy Overview." http://www.aaaai.org/conditions-and-treatments/allergies/skin-allergy.aspx. Accessed August 6, 2013.



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