The space for oral rheumatoid arthritis treatments will not be quite as full as some might have thought. Gilead Sciences (NASDAQ: VALID) told investors on Tuesday that the FDA has issued a full response letter (CRL) denying approval for its drug candidate filgotinib – for now – and handling a huge blow to the company’s cashstream projections.
An FDA approval for filgotinib was widely expected, and predictions of its market potential suggested it was likely to become a blockbuster. Sales were expected to exceed $ 1 billion in 2022 and exceed $ 4 billion annually.
This delay for Gilead’s drug will give recently launched oral rheumatoid arthritis (RA) treatments of AbbVie (NYSE: ABBV) en Eli Lily (NYSE: LLY) more time to establish their footing in the highly lucrative market for immune system suppressants that safely prevent the disease from continuing.
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The injectable RA treatment from AbbVie, Humira is the world’s top-selling drug; its annual sales reached $ 19.9 billion in 2018. In 2019, AbbVie launched Rinvoq, an oral RA treatment similar to filgotinib that generated an annual $ 596 million in the second quarter.
Rinvoq and a similar RA treatment from Eli Lilly called Olumiant are both associated with life-threatening blood clots, although this side effect has been extremely uncommon. Because it has exhibited less serious side effects during clinical trials, it was expected that filgotinib would give Rinvoq and Olumiant fierce competition.
According to Gilead Sciences, the FDA wants to see data from ongoing studies designed to measure whether filgotinib affects sperm counts. An ongoing study to assess testicular safety that began in 2017 is not expected to produce preliminary results until January 2021, meaning it will be at least a year before the FDA revisits filgotinib.
