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Gilead to Submit NDA for Inflammation Drug Filgotinib in '19

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Gilead Sciences (GILD - Free Report) announced that it is planning to submit a new drug application (“NDA”) seeking approval for its oral JAK1 inhibitor, filgotinib, as a treatment for rheumatoid arthritis (“RA”) in 2019. The decision was taken by the company following a pre-NDA meeting with the FDA.

The NDA will likely include data from the ongoing phase III clinical program, FINCH, which comprises three studies. The company had discussion on the phase III FINCH studies with the regulatory authority during the pre-NDA meeting. In 2016, the company had collaborated with Galapagos (GLPG - Free Report) for the development and commercialization of filgotinib, for inflammatory disease indications including RA.

Shares of Gilead have increased 8.4% so far this year compared with the industry’s rise of 5.3%.

The 52-week phase III study, FINCH 1 evaluated filgotinib in comparison with AbbVie’s (ABBV - Free Report) Humira (adalimumab) or placebo on a stable background dose of methotrexate (“MTX”) in patients with prior inadequate response to methotrexate. In March, the company announced 24-week data from the study. The study achieved its primary endpoint for both doses of filgotinib — 100 mg and 200 mg. Filgotinib demonstrated significantly higher ACR20/50/70 responses compared to placebo in patients with prior inadequate methotrexate response. The higher dose of filgotinib also demonstrated non-inferiority to Humira.

The company also announced 24-week data from the ongoing phase III FINCH 3 study in the same month. The study evaluated 100mg or 200mg doses of filgotinib in combination with MTX and as monotherapy in MTX-naive patients. Both the doses of filgotinib in combination with MTX demonstrated significantly higher ACR20/50/70 responses than methotrexate alone. The study achieved its primary endpoint, as higher percentage of patients achieved the primary endpoint of ACR20 response at week 24 for filgotinib 200 mg plus MTX and filgotinib 100 mg plus MTX compared with MTX alone.

In September 2018, Gilead announce top-line data from the phase FINCH 2 study, which evaluated filgotinib in patients receiving conventional synthetic disease-modifying anti-rheumatic drug (DMARD) and prior inadequate response/intolerance to biologic DMARD. The study achieved its primary endpoint in the proportion of patients achieving an American College of Rheumatology 20% response (ACR20) at week 12.  Both the doses — 100 mg and 200 mg — achieved significantly higher ACR20/50/70 responses than placebo in patients with active rheumatoid arthritis and prior inadequate response to biologic agents.

Meanwhile, interim safety data from the phase III FINCH program along with updated week 156 safety data from the phase IIb DARWIN 3 long-term extension study showed that the safety profile of the candidate was consistent with previous studies.

The FINCH studies are among several clinical trials of filgotinib in inflammatory diseases including ulcerative colitis.

Gilead is looking to expand into HIV and newer avenues to boost its top line and offset the loss of sales in HCV products. A potential approval to filgotinib for RA and successful development in other inflammation indications are expected to favorably impact the company’s revenues as the targeted indication has significant market opportunity. We note that Eli Lilly (LLY - Free Report) received approval for Olumiant as a treatment for RA last year. Several other pharma companies are developing their drugs for inflammation indications including RA.

Zacks Rank

Gilead currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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