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FDA Approves Genentech’s Xolair (Omalizumab) Prefilled Syringe Formulation

September 28, 2018

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Sep 28, 2018--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved 75 mg/0.5 mL and 150 mg/1 mL single-dose prefilled syringes (PFS) for Xolair ® (omalizumab) as an additional formulation for both allergic asthma and chronic idiopathic urticaria (CIU) indications. The new Xolair PFS formulation is expected to be available by the end of this year for the first time in the U.S. Xolair is currently available in a 150 mg single-dose vial with lyophilized, sterile powder for reconstitution.

“Xolair has long been an important treatment option for people with allergic asthma and CIU,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “The prefilled syringe formulation reflects our continued commitment to provide healthcare professionals with choices to best support each patient’s unique needs.”

The Xolair PFS eliminates the need for healthcare providers to procure Sterile Water for Injection (SWFI) and reconstitute Xolair before administering the medicine.

Xolair is approved for the treatment of moderate to severe persistent allergic asthma in people six years of age or older whose asthma symptoms are not controlled by inhaled corticosteroids, and for CIU in people 12 years of age and older who continue to have hives that are not controlled by H1 antihistamines. Over 330,000 people in the U.S. have been treated with Xolair since its initial approval for people 12 years and older with allergic asthma in 2003.

About allergic asthma and chronic idiopathic urticaria

Asthma is a serious and chronic lung disease affecting an estimated 26 million people in the U.S. It causes swelling and narrowing of the airways, making breathing difficult. Allergic asthma, the most common form of asthma, accounts for approximately 60 percent of asthma cases in adults.

Chronic idiopathic urticaria (CIU) is a skin condition that can cause hives and severe itch that can last many months and years. CIU is characterized by hives that spontaneously occur without an identifiable cause, and recur for six weeks or more. It is estimated that approximately 1.5 million people in the U.S. have CIU.

About Xolair

Xolair is the only approved antibody designed to target and block immunoglobulin E (IgE). By reducing free IgE, down-regulating high-affinity IgE receptors and limiting mast cell degranulation, Xolair minimizes the release of mediators throughout the allergic inflammatory cascade.

In the U.S., Genentech and Novartis Pharmaceuticals Corporation work together to develop and co-promote Xolair. Genentech is a leading biotechnology company that discovers, develops, manufacturers and commercializes medicines to treat patients with serious or life-threatening medical conditions. Novartis Pharmaceuticals Corporation is an affiliate of Novartis which provides innovative healthcare solutions that address the evolving needs of patients and societies.

Xolair U.S. Indication

Xolair for subcutaneous use is an injectable prescription medicine approved by the FDA to treat:

Moderate to severe persistent asthma in patients six years of age or older whose asthma symptoms are not controlled by asthma medicines called inhaled corticosteroids. A skin or blood test is performed to see if a patient has allergies to year-round allergens. Chronic idiopathic urticaria (CIU; chronic hives without a known cause) in patients 12 years of age and older 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, acute bronchospasm or status asthmaticus.

Important Safety Information

The most important information patients should know about Xolair is that 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.

Before receiving Xolair, patients must tell their healthcare provider about all of their medical conditions, including if they:

have a latex allergy or any other allergies (such as food allergy or seasonal allergies). The needle cap on the Xolair prefilled syringe may contain latex. have sudden breathing problems (bronchospasm) have ever had a severe allergic reaction called anaphylaxis 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. are breastfeeding or plan to breastfeed. It is not known if Xolair passes into breast milk. Talk with your healthcare provider about the best way to feed your baby while you receive Xolair.

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 1 or more injections under the skin (subcutaneous), 1 time every 2 or 4 weeks. In asthma patients, a blood test for a substance called IgE must be performed prior to starting Xolair to determine the appropriate dose and dosing frequency. In patients with chronic hives, a blood test is not necessary to determine the dose or dosing frequency. Patients must not decrease or 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 regarding the risk of anaphylaxis. Cancer. Cases of cancer were observed in some people who received Xolair. Inflammation of your blood vessels. Rarely, this can happen in people with asthma who receive Xolair. This usually, but not always, happens in people who also take a steroid medicine by mouth that is being stopped or the dose is being lowered. It is not known whether this is caused by Xolair. Tell your healthcare provider right away if you have rash; chest pain; shortness of breath; or a feeling of pins and needles or numbness of your arms or legs. Fever, muscle aches, and rash. Some people who take Xolair get these symptoms 1 to 5 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. Heart and circulation problems. Some people who receive Xolair have had chest pain, heart attack, blood clots in the lungs or legs, or temporary symptoms of weakness on one side of the body, slurred speech, or altered vision. It is not known whether these are caused by Xolair.

The most common side effects of Xolair:

In adults and children 12 years of age and older with asthma: pain especially in the arms and legs, dizziness, feeling tired, skin rash, bone fractures and pain or discomfort of the ears. In children 6 to less than 12 years of age with asthma: common cold symptoms, headache, fever, sore throat, pain or discomfort of your ear, abdominal pain, nausea, vomiting and nose bleeds. 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 at for additional Important Safety Information.

About Xolair Access Solutions

Patients experiencing financial hardship may be eligible to receive coverage and reimbursement support for Xolair. Patient assistance and informational resources are available through Xolair Access Solutions ( http://www.xolair.com/allergic-asthma/xolair-access-solutions.html ).

About Genentech

Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and 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.

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CONTACT: Genentech

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KEYWORD: UNITED STATES NORTH AMERICA CALIFORNIA

INDUSTRY KEYWORD: HEALTH BIOTECHNOLOGY PHARMACEUTICAL FDA MEDICAL SUPPLIES

SOURCE: Genentech

Copyright Business Wire 2018.

PUB: 09/28/2018 05:00 PM/DISC: 09/28/2018 05:01 PM

http://www.businesswire.com/news/home/20180928005624/en

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