Xolair awarded BTD for food allergy indication
The US Food and Drug Administration (FDA) has awarded Roche and Novartis’ allergy drug Xolair (omalizumab) Breakthrough Therapy Designation (BTD) for its new food allergy indication.
The drug made its debut in the US 15 years ago as an asthma treatment, and has since then also gained a dermatology indication for the treatment of chronic idiopathic urticaria (hives).
“Food allergies can have a significant impact on the lives of children and adults, and they are a growing public health concern for which there are currently no FDA-approved treatments,” said Sandra Horning, Chief Medical Officer and Head of Global Product Development. “We are committed to helping address this high unmet medical need and look forward to working with leaders in the field to further develop Xolair as a potential medicine to help people with this condition that can be life-threatening.”
The hope is that there will be a supplemental approval for the drug in the coming years. In 2017, Roche booked global sales of Xolair of about $1.7 billion and Novartis posted revenue of $920 million.