Friday, Mar 21, 2014
South San Francisco, Calif. -- March 21, 2014 --
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) approved Xolair ® (omalizumab) for the treatment of chronic idiopathic urticaria (CIU), a form of chronic hives. The new use is for people 12 years of age and older who remain symptomatic despite treatment with H1-antihistamine therapy5. Until now, H1-antihistamines have been the only approved therapy for CIU, with about 50 percent of patients having an inadequate response3.
CIU is diagnosed when hives occur without an identifiable cause, spontaneously present, and reoccur for more than six weeks1,3. CIU can have burdensome symptoms including swelling, severe itch, pain, and discomfort that may last for many months and even years1,2. Approximately 1.5 million people in the U.S. develop CIU at some stage in their life3,4. Women are twice as likely as men to experience CIU and most develop symptoms between the ages of 20 and 403,6.
“Chronic idiopathic urticaria can be difficult to manage because its causes are unknown, and other approved medicines aren't effective enough for many patients,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “We are pleased to have Xolair as a new option for people with this serious skin condition.”
Xolair is the first biologic medicine and first medicine approved by the FDA for CIU since non-sedating H1-antihistamines. Xolair is approved for people 12 years and older with CIU who remain symptomatic despite treatment with H1-antihistamine therapy5. Xolair is not used to treat other forms of urticaria (hives) and is not for use in children less than 12 years of age. It is jointly developed by Genentech and Novartis Pharma AG and is co-promoted in the U.S. with Novartis Pharmaceuticals Corporation.
“CIU can be a frustrating condition for patients,” said Mike Tringale, senior vice president at the Asthma and Allergy Foundation of America (AAFA). “This new use for Xolair gives hope to appropriate patients who can go for months or even years without getting satisfactory itch and hive reduction.”
The efficacy and safety profile of Xolair for the treatment of CIU was evaluated in two clinical studies called ASTERIA I and ASTERIA II5. In these studies, patients 12 to 75 years old received doses of Xolair at 150 mg, 300 mg or placebo5. Xolair or placebo was given every four weeks for 24 weeks (ASTERIA I) and 12 weeks (ASTERIA II). In addition, patients continued to receive H1-antihistamine medicines they had been taking for CIU before starting treatment with Xolair5.
Efficacy and Safety Findings
The efficacy of Xolair in patients 12 years and older who remained symptomatic despite taking H1-antihistamines was assessed using a scale known as the average (mean) weekly Itch Severity Score (ISS) at Week 12. The weekly ISS has potential scores ranging from 0 to 215. In ASTERIA I, Xolair 150 mg improved ISS from the starting measurement by 47 percent (-6.7) and Xolair 300 mg improved ISS from the starting measurement by 66 percent (-9.4) at Week 12, compared to a 25 percent (-3.6) score improvement for patients who received placebo5. Also, a larger proportion of patients (36 percent) treated with Xolair 300 mg reported no itch and no hives at Week 12, compared to patients treated with Xolair 150 mg (15 percent), and patients in the placebo group (9 percent)5. Similar results were observed for the ASTERIA II study5.
The most common side effects in patients treated with Xolair were nausea, headaches, swelling of the inside of the nose, throat or sinuses, cough, joint pain, and upper respiratory tract infection5.
Xolair for subcutaneous use is an injectable prescription medicine used to treat adults and children 12 years of age and older with:
Xolair is not used to treat other allergic conditions, other forms of urticaria (hives), acute bronchospasm (serious and sudden breathing problems) or status asthmaticus (acute, severe, prolonged asthma attack that can be life threatening). Xolair is not for use in children less than 12 years of age.
Important Safety Information
A severe allergic reaction called anaphylaxis can happen when a patient receives Xolair. The reaction can occur after the first dose, or after many doses. It may also occur right after a Xolair injection or days later. Anaphylaxis is a life-threatening condition and can lead to death. Patients must go to the nearest emergency room right away if they have any of these symptoms of an allergic reaction:
The patient’s healthcare provider will monitor the patient closely for symptoms of an allergic reaction while they are receiving Xolair and for a period of time after the patient’s injection. The patient’s healthcare provider should talk to the patient about getting medical treatment if they have symptoms of an allergic reaction after leaving the healthcare provider’s office or treatment center.
Patients must not receive Xolair if they are allergic to omalizumab or any of the ingredients in Xolair.
Before receiving Xolair, patients must tell their healthcare provider about all of their medical conditions, including if they:
Patients must tell their healthcare provider about all the medicines they take, including prescription and over-the-counter medicines, vitamins, or herbal supplements.
Possible side effects of Xolair:
Xolair may cause serious side effects, including:
The most common side effects of Xolair:
These are not all the possible side effects of Xolair. Patients should call their doctor for medical advice about side effects.
Please see full Prescribing Information, including Medication Guide for additional important safety information at http://www.xolair.com.
About Genentech Access Solutions
Genentech is committed to people having access to its medicines. Genentech Access Solutions is a team of more than 350 Genentech employees who help those who need its medicines. Knowledgeable and experienced specialists can help patients and medical practices navigate the access and reimbursement process and provide assistance to eligible patients in the U.S. who do not have insurance coverage or who cannot afford their out-of-pocket co-pay costs. For more information, please visit http://www.Genentech-Access.com.
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.
The Asthma and Allergy Foundation of America (AAFA) is a not-for-profit organization founded in 1953. AAFA is the leading patient organization for people with asthma, allergies and related conditions, and provides practical information, community based services and support through a national network of chapters and support groups. AAFA develops health education, organizes state and national advocacy efforts and funds research to find better treatments and cures. Learn more about AAFA at http://www.aafa.org.
1 Asthma and Allergy Foundation of America (AAFA) website. “Chronic Urticaria (Hives).” http://www.aafa.org/display.cfm?id=9&sub=23&cont=328. Accessed March 11, 2014.
2 American Academy of Allergy Asthma & Immunology (AAAAI) website. “Skin Allergy Overview.” http://www.aaaai.org/conditions-and-treatments/allergies/skin-allergy.aspx . Accessed March 11, 2014.
3 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.
4 Census Bureau Projects U.S. Population of 317.3 Million on New Year's Day. United States Census Bureau. December 30, 2013. http://www.census.gov/newsroom/releases/archives/population/cb13-tps112.html . Accessed March 11, 2014
5 Xolair® Full Prescribing Information. Genentech. March 21, 2014
6 S. Saini. Chronic urticaria: Clinical manifestations, diagnosis, pathogenesis, and natural history. http://www.uptodate.com/contents/chronic-urticaria-clinical-manifestations-diagnosis-pathogenesis-and-natural-history . Accessed March 11, 2014.
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