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Gilead (GILD) Files NDA for RA Candidate Filgotinib in Japan

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Gilead Sciences, Inc. (GILD - Free Report) announced that it has submitted a new drug application (NDA) for its oral JAK1 inhibitor filgotinib to treat adult patients with rheumatoid arthritis (RA) in Japan.

The NDA submitted to the Japanese Ministry of Health, Labor and Welfare was based on data from the phase III clinical program FINCH, which comprises three studies. Data from the study showed that once-daily treatment with filgotinib demonstrated the potential to improve clinical signs and symptoms, and achieved low disease activity and remission.

Importantly, safety results across the FINCH program were consistent with previously reported data.

The 52-week phase III study FINCH 1 evaluated filgotinib compared to AbbVie’s (ABBV - Free Report) Humira (adalimumab) or placebo on a stable background dose of methotrexate (MTX) in patients with prior inadequate response to MTX.

In March, the company announced 24-week data from the study. The same achieved its primary endpoint for both doses of filgotinib — 100 mg and 200 mg – measured by response on the scale of American College of Rheumatology (ACR).

The phase III FINCH 3 study evaluated 100 mg or 200 mg doses of filgotinib in combination with MTX and as monotherapy in MTX-naive patients.

The FINCH 2 study evaluated filgotinib in patients receiving conventional, synthetic disease-modifying anti-rheumatic drug (DMARD) and having prior inadequate response to one or more biological therapies.

Shares of Gilead have lost 1.4% so far this year compared with the industry’s decrease of 8.6%.

In August 2019, Gilead and partner Galapagos (GLPG - Free Report) announced that the European Medicines Agency (EMA) has accepted their marketing authorization application (MAA) for filgotinib as a treatment for RA in Europe.

Notably, a potential approval of filgotinib for RA and successful development in other inflammation indications are expected to favorably impact Gilead’s revenues as the targeted indication has a significant market opportunity. However, filgotinib is likely to face competition from Eli Lilly’s (LLY - Free Report) Olumiant, which is already approved as a treatment for RA. Several other pharma companies are also developing drugs for inflammation indications including RA.

Zacks Rank

Gilead currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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