FDA accepts Genentech’s sBLA for Xolair

The FDA has accepted Roche (OTCQX:RHHBY) unit Genentech’s supplemental Biologics License Application (sBLA) for Xolair (omalizumab) for the treatment of nasal polyps in adult patients with inadequate response to intranasal corticosteroids.

If approved, Xolair would become the first antibody to help reduce the size of nasal polyps and help improve symptoms through targeting and blocking immunoglobulin E. The FDA approval is expected by Q3 2020.

The company is developing and co-promoting the IgE blocker in the U.S. with Novartis (NYSE:NVS).

https://seekingalpha.com/news/3525421-fda-accepts-genentechs-sbla-for-xolair