Roche Holding's SBLA For Xolair Granted Priority Review By FDA

(RTTNews) - Roche Holding AG (RHHBY) made an announcement on Tuesday stating that the FDA has accepted the company's supplemental Biologics License Application (sBLA) for Xolair (omalizumab).

The sBLA has been accepted under Priority Review for the reduction of allergic reactions, including anaphylaxis, that may occur due to accidental exposure to one or more foods for patients aged 1 year and older with food allergies.

The company stated that the filing acceptance was based on positive interim analysis results from Stage 1 of the National Institutes of Health (NIH)-sponsored pivotal Phase III OUtMATCH study, which showed that Xolair significantly increased the amount of peanut (primary endpoint) and milk, egg, and cashew (key secondary endpoints) it took to cause an allergic reaction in patients with food allergies when compared to placebo.

In case of approval, Xolair will be the first medicine to reduce allergic reactions to multiple foods following an accidental exposure.

The approval by the FDA is expected in the first quarter of 2024.