FDA Denies Approval for Gilead Sciences' Potential Blockbuster Arthritis Drug

The space for oral rheumatoid arthritis treatments won't be getting crowded quite as quickly as some might have been expecting. Gilead Sciences (NASDAQ: GILD) told investors on Tuesday that the FDA has issued a complete response letter (CRL) denying approval for its drug candidate filgotinib -- for now -- and dealing a huge blow to the company's cash flow projections.

An FDA approval for filgotinib had been widely expected, and forecasts of its market potential suggested it would likely become a blockbuster. Sales had been expected to exceed $1 billion in 2022 and peak above $4 billion annually.

This setback for Gilead's drug will give recently launched oral rheumatoid arthritis (RA) treatments from AbbVie (NYSE: ABBV) and Eli Lily (NYSE: LLY) more time to establish their footholds in the highly lucrative market for immune system suppressants that safely prevent the disease from progressing. 

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Source Fool.com