Gilead Sciences, Inc. GILD and its Japanese partner, Eisai, announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has granted regulatory approval to rheumatoid arthritis (RA) drug, Jyseleca (filgotinib 200 mg and 100 mg tablets).
Jyseleca, a once-daily, oral, JAK1 preferential inhibitor, has been approved in Japan for the treatment of RA in patients who have had an inadequate response to conventional therapies, including the prevention of structural joint damage.
Gilead will hold the marketing authorization of Jyseleca in Japan and be responsible for the supply of Jyseleca in Japan. Meanwhile, Eisai will be responsible for the distribution of Jyseleca in Japan for RA.
The approval in Japan is based on positive results from the phase III, FINCH, and phase II DARWIN studies, wherein patients receiving Jyseleca once daily showed improvements in clinical signs and symptoms, decreases in disease activity and less progression of structural damage in their joints.
We remind investors that Gilead is developing Jyseleca in collaboration with Galapagos NV GLPG. However, last month, the company suffered a setback when the FDA has issued a complete response letter (CRL) for the New Drug Application (NDA) for filgotinib, for 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.
Gilead and Galapagos have multiple clinical study 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.
A potential approval of the candidate for RA and the 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 Olumiant, which is already approved as a treatment for RA. Several other pharma companies are also developing drugs for inflammation indications, including RA.
Gilead’s shares have lost 4.2% in the year so far compared with the industry’s decline of 0.9%.
The company has been in the news since the onset of the year as it leads the race against the coronavirus disease with its investigational antiviral, Veklury.
Gilead currently carries a Zacks Rank #3 (Hold). Horizon Therapeutics HZNP is a better-ranked stock in the biotech sector, sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Horizon’s earnings per share estimates have increased 3 cents in the past seven days for 2020 and 6 cents for 2021. The company’s shares have surged 120.4% year to date.
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