Roche: FDA accepts supplemental application for Xolair

(CercleFinance.com) - Roche said US health regulators accepted its application for the use of its Xolair antibody for the treatment of nasal polyps.


The Food and Drug Administration (FDA) has accepted the drugmaker's supplemental biologics license application for the treatment of nasal polyps in adult patients 18 years of age and older with inadequate response to intranasal corticosteroids.

If approved, Xolair would become the first antibody to help reduce the size of nasal polyps.

The FDA is expected to make a decision on approval by the third quarter of 2020.

Roche and Novartis work together to develop and promote Xolair in the US.

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