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FDA approves additional Xolair formulations

The FDA has approved 75 mg/0.5 mL and 150 mg/1 mL single-dose prefilled syringes of Xolair as additional formulations for patients with allergic asthma and chronic idiopathic urticaria, according to press releases from Genentech and Novartis.

Xolair (omalizumab, Genentech and Novartis) was previously approved for the treatment of moderate to severe persistent allergic asthma in patients older than 6 years whose asthma symptoms are not controlled by inhaled corticosteroids, and for chronic idiopathic urticaria in patients older than 12 years who continue to have hives that are not controlled by H1 antihistamines.

The new formulations allow clinicians to administer omalizumab without securing sterile water and reconstituting the medication before using it, according to the companies.

“Xolair has long been an important treatment option for people with allergic asthma and [chronic idiopathic urticaria],” Sandra Horning, MD, Genentech’s chief medical officer and head of global product development, said in a press release. “The prefilled syringe formulation reflects our continued commitment to provide health care professionals with choices to best support each patient's unique needs.”

“The approval of Xolair prefilled syringe is part of our continuing commitment to people with allergic asthma and [chronic idiopathic urticaria],” Fabrice Chouraqui, president of Novartis Pharmaceuticals Corporation’s U.S. operations, said in a separate press release. “We’re reimagining medicine with meaningful therapies and various delivery systems to meet the evolving needs of healthcare professionals and patients.”

The companies stated that the most common adverse events for children aged 6 to 12 years with asthma that received omalizumab were abdominal pain, common cold symptoms, fever, headache, nausea, nose bleeds, pain or discomfort in the ear, sore throat and vomiting. Adults and children older than 12 years receiving omalizumab most commonly reported bone fractures, dizziness, feeling tired, pain in the arms and legs, pain or discomfort of the ears and skin rash. The most common adverse events reported in patients with chronic idiopathic urticaria were cough, headaches, joint pain, nausea, swelling of the inside of the nose, throat or sinuses, and upper respiratory tract infections.

The new formulations of omalizumab should be available by the end of this year, according to Genentech.

Disclosures: Horning works for Genentech, Chouraqui works for Novartis Pharmaceuticals Corporation.