Roche Asthma Drug Xolair Gets FDA Nod For Label Expansion

Roche Holding (SIX:ROG) AG (OTC:RHHBY) announced that the FDA has approved a label expansion of respiratory drug, Xolair.

The drug is now approved for the treatment of moderate-to-severely persistent asthma in children aged 6 to 11 years, who have had a positive skin test or in vitro reactivity to an airborne allergen, along with symptoms that are inadequately controlled with inhaled corticosteroids.

We note that the drug is already approved for the treatment of allergic asthma patients aged 12 years and older. Xolair is also approved for the treatment of chronic idiopathic urticaria (CIU) in patients aged 12 years and older, who continue to have hives that are not controlled by an H1 antihistamine treatment.

The latest label expansion to include the treatment of a younger group of children should further boost sales of the drug. As per the U.S. Centers for Disease Control and Prevention, asthma affects 6.3 million people under 18, or one in every 12 children in the U.S. Out of this, approximately 60% have allergic asthma. As per estimates from the American Academy of Pediatrics, 70% to 80% of school-aged children with asthma also have allergies. This reflects significant need for treatments in this indication.

Roche has a collaboration agreement with Novartis AG (NYSE:NVS) for Xolair, under which Novartis is responsible for the commercialization of Xolair outside the U.S., while Roche markets the product in the U.S.

We are impressed by the company's efforts to grow its portfolio beyond oncology and foray into new avenues such as multiple sclerosis and asthma. Roche currently has more than a dozen candidates in its pipeline for diseases like Alzheimer’s disease, spinal muscular atrophy and Parkinson’s disease among others.

The company currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the healthcare sector include Pfizer, Inc. (NYSE:PFE) and Johnson & Johnson (NYSE:JNJ) . Both the stocks carry a Zacks Rank #2 (Buy).