BioPharma

Gilead to seek FDA approval for rheumatoid arthritis drug this year

The timing of the filing appears to allay concerns that the FDA would require completion of a study evaluating the testicular safety of the drug, filgotinib, and thus push its launch date from 2020 to 2021-22, an analyst wrote.

A U.S. biotech company plans to seek Food and Drug Administration approval for a drug to treat autoimmune diseases this year.

Foster City, California-based Gilead Sciences said Monday that it would file an approval application for filgotinib. The company said its determination follows a discussion with the FDA about the Phase III FINCH studies, in patients with rheumatoid arthritis, and the Phase II MANTA study, evaluating reproductive health among men taking filgotinib for ulcerative colitis or Crohn’s disease. The drug, a JAK1 inhibitor, is being developed under a partnership between Gilead and Mechelen, Belgium-based Galapagos, announced in December 2015.

Shares of Gilead were up 1.4 percent on the Nasdaq Tuesday morning following the news. Shares of Galapagos were up more than 4 percent on the Euronext Amsterdam and the Nasdaq.

The Phase III studies, FINCH 1 and FINCH 3, have both achieved their primary endpoints, showing that patients receiving filgotinib demonstrated statistically significant response rates compared with those receiving placebo. Both trials used the American College of Rheumatology 20 percent response, also known as ACR20, as their primary endpoints. The proportion of patients achieving 50 percent and 70 percent responses was also higher for the filgotinib group than the placebo group.

Concerns about potential testicular toxicity have been an issue for the drug. In March, SVB Leerink analyst Geoffrey Porges wrote that if the FDA requires the company to complete the MANTA study before approving filgotinib, that could push its launch date from 2020 to 2021 or 2022. MANTA’s primary completion date is January 2021.

Nevertheless, Cowen analyst Phil Nadeau wrote in a note to investors Tuesday that had the FDA required results from MANTA, which the companies had conducted at the agency’s request, it is unlikely they would have filed before 2021. Given that investors’ hopes that the FDA would not require the MANTA data before considering the drug, and no testicular toxicity has been observed among men in the FINCH studies, “today’s announcement represents the best case outcome that puts filgotinib on pace for a 2020 U.S. launch,” Nadeau wrote.

Filgotinib’s main competition comes from two other JAK inhibitors in development for autoimmune diseases: AbbVie’s upadacitinib, for which that company filed for FDA approval in February; and Pfizer’s Xeljanz (tofacitinib), which is already approved for rheumatoid arthritis, psoriatic arthritis and ulcerative colitis.

Photo: Tomsmith585, Getty Images

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