The FDA has approved Roche’s (OTCQX:RHHBY) asthma drug Xolair, which was developed by Roche unit Genentech, for the additional indication of reducing allergic reactions, including life-threatening anaphylaxis, in people with food allergies.
Xolair was approved to help reduce allergic reactions to multiple foods after accidental exposure. The product is meant to be taken on a regular basis and not intended for emergency treatment of allergic reactions, according to the FDA.
The product is now approved for use in certain adults and children aged one year and older who have at least one IgE-mediated food allergy, including peanuts, milk, eggs, wheat and certain nuts. It carries a boxed warning for anaphylaxis and should be started in a healthcare setting equipped to manage such reactions.
Xolair was originally approved for the treatment of moderate-to-severe persistent allergic asthma in certain patients. It’s since been approved for chronic spontaneous urticaria, or hives, and chronic rhinosinusitis with nasal polyps in certain patients.
Genentech is an independent subsidiary of Roche.