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Gilead's (GILD) Filgotinib MAA for RA Accepted in Europe

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Gilead Sciences GILD and partner Galapagos GLPG announced that the European Medicines Agency (“EMA”) has accepted their marketing authorization application (“MAA”) related to JAK inhibitor candidate, filgotinib. The MAA is seeking approval of the drug as a treatment for rheumatoid arthritis (“RA”) in Europe.

The MAA includes data from the phase III clinical program, FINCH, which comprises three studies. Data from the studies have shown that once-daily treatment with filgotinib improved clinical signs and symptoms, and achieved low disease activity and remission. The candidate also inhibited structural damage in different sub-populations of RA patients.

In July, the company announced its plan to submit a new drug application to the FDA for filgotinib, seeking approval in similar indication, by the end of the year.

Shares of Gilead have increased 0.5% so far this year against the industry’s decline of 3.4%.

The 52-week phase III study, FINCH 1, evaluated filgotinib in comparison with AbbVie’s ABBV 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 study 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 drug 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.

In the same month, the company also announced 24-week data from the ongoing phase III FINCH 3 study. The study evaluated 100 mg or 200 mg doses of filgotinib in combination with MTX and as monotherapy in MTX-naive patients. Both doses of filgotinib in combination with MTX demonstrated significantly higher ACR20/50/70 responses than MTX alone. The study achieved its primary endpoint, as higher percentage of patients achieved the 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 announced top-line data from the phase FINCH 2 study, which evaluated filgotinib in patients receiving conventional, synthetic disease-modifying anti-rheumatic drug (DMARD) and showing 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 doses — 100 mg and 200 mg — achieved significantly higher ACR20/50/70 responses than placebo in patients with active RA and prior inadequate response to biologic agents.

In July, Gilead expanded its collaboration with Galapagos by signing a 10-year global research and development agreement for an upfront payment of $3.95 billion and $1.1 billion of equity investment in the latter. Galapagos is also eligible to receive a significant amount in milestone payments. The deal will provide Gilead exclusive product license and option rights to develop and commercialize an innovative portfolio of compounds, which includes six molecules in clinical-stage development, more than 20 preclinical programs and a proven drug discovery platform in all countries outside Europe.

Notably, Eli Lilly LLY received approval for Olumiant as a treatment for RA last year. Several other pharma companies are developing drugs for inflammation indications, including RA.

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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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