Gilead Sciences, Inc. GILD and partner Galapagos NV GLPG announced that the European Commission (EC) has granted marketing authorization to rheumatoid arthritis (RA) drug, Jyseleca (filgotinib 200 mg and 100 mg tablets).
Jyseleca is a once-daily, oral, JAK1 inhibitor, which has been approved for the treatment of adults with moderate to severe active RA who have responded inadequately to or are intolerant to one or more disease modifying anti-rheumatic drugs (DMARDs). The drug can be used as monotherapy or in combination with methotrexate (MTX).
Per estimates, the market potential for Jyseleca is quite significant as approximately 3 million people in Europe suffer from RA. Among these, many do not achieve long-term symptom control, which can lead to more frequent symptom flares and disease progression, and can significantly impact their quality of life.
The approval was based on positive data from the phase III FINCH and phase II DARWIN programs.
Per the agreement, Galapagos will now receive a milestone payment of $75 million following the approval of Jyseleca by the European Commission.
Last week, Gilead and partner Eisai obtained approval of Jyseleca for this indication in Japan.
While the drug’s approval in Europe and Japan bodes well for Gilead, its efforts to obtain an approval in the United States suffered a setback.
Last month, the FDA issued a complete response letter (CRL) for the New Drug Application (NDA) for filgotinib, for the treatment of moderately to severely active RA. The agency has now requested data from the MANTA and MANTA-RAy studies before completing its review of the NDA. These studies are designed to assess if filgotinib has an impact on sperm parameters. Additionally, the FDA has some concerns regarding the overall benefit/risk profile of the filgotinib 200 mg dose. Both studies are fully recruited and top-line results are expected in the first half of 2021.
The CRL will result in a delay in the approval of the candidate. Nevertheless, Gilead and Galapagos have multiple programs for filgotinib in inflammatory diseases, including the FINCH phase III program in RA, the phase III SELECTION trial in ulcerative colitis, the DIVERSITY phase III study in Crohn’s disease, the phase III PENGUIN studies in psoriatic arthritis and the phase II studies for uveitis, small bowel and fistulizing Crohn’s disease.
The approval of the candidate and the successful development in other indications are expected to favorably impact Gilead’s revenues.
The company’s shares have lost 2.7% in the year so far against the industry’s growth of 1.4%.
The massive decline in sales of Gilead’s HCV franchise has propelled it to focus on its HIV franchise, Yescarta and other newer avenues.
However, Jyseleca is likely to face competition from AbbVie’s ABBV Humira and Eli Lilly’s LLY Olumiant, which are already approved as a treatment for RA.
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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