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The space for oral rheumatoid arthritis treatments will not be crowded as quickly as some might have expected. Gilead Sciences (NASDAQ: GILD) told investors on Tuesday that the FDA issued a full response letter (CRL) denying approval of its drug candidate filgotinib – for now – and dealing a blow to the company’s cash flow projections.
FDA approval for filgotinib was widely expected, and predictions of its market potential suggested that it would likely become a blockbuster. Sales are expected to exceed $ 1 billion in 2022 and peak above $ 4 billion annually.
Gilead’s drug failure will result in newly launched oral treatments for rheumatoid arthritis (RA) AbbVie (NYSE: ABBV) and Eli Lily (NYSE: LLY) more time to gain a foothold in the very lucrative market for immune system suppressants that safely prevent disease progression.
Image source: Getty Images.
AbbVie’s injectable treatment for RA, Humira is the world’s best-selling drug; its annual sales peaked at $ 19.9 billion in 2018. In 2019, AbbVie launched Rinvoq, an oral treatment for rheumatoid arthritis similar to filgotinib that generated an annualized amount of $ 596 million in the second quarter.
Rinvoq and a similar treatment for Eli Lilly’s rheumatoid arthritis called Olumiant have both been linked to life-threatening blood clots, although this side effect has been extremely rare. Since it has shown fewer serious side effects during clinical trials, filgotinib is expected to give Rinvoq and Olumiant stiff competition.
According to Gilead Sciences, the FDA wants to see data from ongoing studies designed to measure whether or not filgotinib has an impact on sperm count. An ongoing study to assess the safety of the testes that began in 2017 is not expected to produce preliminary results until January 2021, which means it will be at least another year before the FDA looks at filgotinib again.
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