Xolair Gains FDA Nod for Adults with Nasal Polyps

The FDA has approved a supplemental Biologics License Application (sBLA) from Roche and Novartis for Xolair (omalizumab) for the treatment of nasal polyps in adults over 18 years who don’t respond to corticosteroids.

The drug works by inhibiting immunoglobulin E, which causes inflammation leading to polyps. The approval was supported by results from two phase 3 trials demonstrating that patients receiving Xolair showed significantly greater improvement at week 24 vs. a placebo.

Xolair was first approved by the FDA in 2003 for the treatment of asthma. The drug earned almost $2.2. billion in U.S. sales for Roche in 2019. Novartis does not record any U.S. sales for the drug. It’s non-U.S. sales for 2019 were $1.2 billion.