FDA OKs New Omalizumab Prefilled Syringe Formulation for Allergic Asthma


The new formulation, known as Xolair PFS, will be available in the US by the end of the year.

The US Food and Drug Administration (FDA) has granted approval to omalizumab (Genentech/Xolair) in a 75 mg/0.5 mL and 150 mg/1 mL single-dose prefilled syringe (PFS) formulation. Omalizumab is the only biologic approved for both allergic asthma and chronic idiopathic urticaria.

Omalizumab was previously available in a 150 mg single-dose vial with lyophilized, sterile powder for reconstitution. The new formulation, known as Xolair PFS, will be available in the US by the end of the year, and eliminates the need for physicians to use Sterile Water for Injection (SWFI) and reconstitute omalizumab before administration, according to a Genentech statement.

Omalizumab “has long been an important treatment option for people with allergic asthma and CIU,” said Sandra Horning, MD, chief medical officer and head of global product development at Genentech. Indeed, the therapy has been used to treat more than 330,000 patients in the last decade and a half, per Genentech.

Approval of the new omalizumab formulation follows the FDA’s granting of Breakthrough Therapy designation to the drug in mid-August for several food allergies. According to reports at the time, omalizumab was granted the designation based on data from 7 clinical trials over the past decade that assessed omalizumab’s efficacy and safety versus various food allergens such as peanut, milk, and egg.

Moreover, Omalizumab has been previously approved by the FDA to treat moderate to severe persistent asthma in patients 6 years or older whose asthma is not controlled by inhaled corticosteroids, as well as chronic idiopathic urticaria in patients 12 years and older who continue to have hives that are not controlled by H1 antihistamine treatment.

Omalizumab is not used to treat other allergic conditions, other forms of urticaria, acute bronchospasm or status asthmaticus.

In late 2017, a real-world omalizumab asthma study found patient response reflected the rates and levels of symptom reduction reported in clinical trials, and that fractional exhaled nitric oxide (FeNO) could be useful in selecting those most likely to respond.

“Often in radmoized controlled clinical trials, patients may be excluded for various reasons,” said Mohit Bhutani, MD, of the Division of Pulmonary Medicine at the University of Alberta, Canada. : The study is helpful to make sure that the effect seen once the product is commercially available is what was seen in the relevant clinical trials.”

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