FDA Approves Xolair® (omalizumab) for People with Chronic Idiopathic Urticaria (CIU), a Form of Chronic Hives

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.

About Xolair

Xolair for subcutaneous use is an injectable prescription medicine used to treat adults and children 12 years of age and older with:

• moderate to severe persistent allergic asthma who have had a skin or blood test that is positive for allergic asthma and whose asthma symptoms are not controlled by asthma medicines called inhaled corticosteroids.
• chronic idiopathic urticaria (CIU; chronic hives without a known cause) who continue to have hives that are not controlled by H1-antihistamine treatment.

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:

• 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

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:

• have any other allergies (such as food allergy or seasonal allergies)
• have sudden breathing problems (bronchospasm)
• have or have had low white blood cell count (patients should ask their doctor if they are not sure)
• have or have had a parasitic infection
• have or have had cancer
• are pregnant or plan to become pregnant. It is not known if Xolair may harm a patient’s unborn baby.
• if a patient becomes pregnant while taking Xolair, they should talk to their healthcare provider about registering with the Xolair Pregnancy Registry. Patients can get more information and register by calling (866) 4XOLAIR (866-496-5247) or visit http://www.xolairpregnancyregistry.com.
• are breastfeeding or plan to breastfeed. It is not known if Xolair passes into breast milk.

Patients must tell their healthcare provider about all the medicines they take, including prescription and over-the-counter medicines, vitamins, or herbal supplements.

Receiving Xolair

• Xolair should be given by a healthcare provider in a healthcare setting.
• Xolair is given in one or more injections under the skin (subcutaneous), one time every two or four weeks.
• The patient’s healthcare provider may do certain tests and change the patient’s Xolair dose as needed.
• Patients must not stop taking any of their other asthma or hive medicine unless their healthcare providers tell them to.
• Patients may not see improvement in their symptoms right away after Xolair treatment.

Possible side effects of Xolair:

Xolair may cause serious side effects, including:

• See “What is the most important information I should know about Xolair?” in the Xolair Medication Guide at http://www.xolair.com
• Cancer. People who receive treatment with Xolair may have a higher chance for getting certain types of cancer.
• Fever, muscle aches, and rash. Some people who take Xolair get these symptoms one to five days after receiving a Xolair injection. If a patient has any of these symptoms, they must tell their healthcare provider.
• Parasitic infection. Some people who are at a high risk for parasite (worm) infections, get a parasite infection after receiving Xolair. The patient’s healthcare provider can test the patient’s stool to check if they have a parasite infection.
• High blood levels of a certain antibody (Serum total IgE)

The most common side effects of Xolair:

• In people with allergic asthma: pain especially in the arms and legs, dizziness, feeling tired, skin rash, bone fractures, and pain or discomfort of the ears.
• In people with chronic idiopathic urticaria: nausea, headaches, swelling of the inside of the nose, throat or sinuses, cough, joint pain, and upper respiratory tract infection.

These are not all the possible side effects of Xolair. Patients should call their doctor for medical advice about side effects.

Report side effects to the FDA at (800) FDA-1088 or http://www.fda.gov/medwatch. Report side effects to Genentech at (888) 835-2555 or Novartis Pharmaceuticals Corporation at (888) 669-6682.

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.

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.

About AAFA

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.

References

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.