Genentech said on Tuesday its supplemental Biologics License Application for Gazyva for lupus has been accepted by the US Food and Drug Administration.
The company, a member of the Roche Group, announced the acceptance in a press release.
The application is based on positive results from the Phase III ALLEGORY study, which demonstrated a statistically significant and clinically meaningful benefit for patients with systemic lupus erythematosus.
FDA acceptance moves the drug one step closer to approval for a new, potentially lucrative market for the most common form of lupus. Approval would diversify Gazyva's revenue stream and strengthen Roche's position in the immunology market.
The acceptance is a positive development for Roche, potentially leading to increased investor confidence and a boost in the company's stock price. Investors will now look forward to the FDA's final decision on the approval of Gazyva for this new indication.
This article is for informational purposes only and does not constitute investment advice.
