FDA grants Breakthrough status for Xolair for food allergies

An established allergy drug has now been granted Breakthrough Therapy designation (BTD), aimed at expediting the development and approval process, by the US Food and Drug Administration in the food allergy space.

Swiss pharma giant Roche (ROG: SIX) says that the FDA) has granted this coveted designation for Xolair (omalizumab) for the prevention of severe allergic reactions following accidental exposure to one or more foods in people with allergies. This is the 23rd Breakthrough Therapy Designation for Roche's portfolio of medicines.

In the USA, Roche subsidiary Genentech and fellow Swiss giant Novartis’ (NOVN: VX) US affiliate work together to develop and co-promote Xolair. In 2017, Roche booked global sales of Xolair of about $1.7 billion and Novartis posted revenue of $920 million.