Gilead plans to apply for approval for the new rheumatoid arthritis drug Filgotinib

pharmaceutical company plans to apply to the U.S. Food and Drug Administration for approval of a new drug for rheumatoid arthritis drug Filgotinib. The company did not provide a specific timetable for when applications for new drugs would be submitted.

's brief announcement this morning comes three months after Gilead and its development partner Galapagos NV announced that its Phase III FINCH 3 trial reached the primary endpoint of the American Rheumatology Society's 20% Response (ACR20) patient remission rate at 24 weeks. Both companies reported a significantly higher proportion of patients treated with ACR20 labels using 200mg methotrexate and 100mg of methotrexate alone than with methotrexate alone. Patients taking the filgotinib combination also had higher rates of ACR50, ACR70 and clinical remission at 24 weeks than methotrexate alone, the companies said. In addition, Gilead noted that the disability index in the patient health assessment questionnaire for patients treated with filgotinib decreased significantly compared to patients treated with MTX at week 24. The company reported in March that the use of Filgotinib 200 mg monotherapy inhibited the development of structural damage at the 24th week compared to the single use of MTX alone.

in its release of THE RESULTS 3 results, John McHutchison, Gilead's head of research and development and chief scientific officer, said the data showed improved efficacy when comparing people with rheumatoid arthritis with early-stage diseases with the use of MTX alone. McHutchison added that the data added evidence to the company's broader FINCH program and reinforced the potential of filgotinib to address the important treatment needs of patients with rheumatoid arthritis.

Filgotinib is a research, oral, selective JAK1 inhibitor suitable for adult patients with moderate to severe active rheumatoid arthritis. FINCH 3 evaluated the single-drug treatment of filgotinib in combination with methotrexate and MTX primary patients.

announcing the FINCH 3 study, Gilead and Galapagos said the phase III FINCH 1 trial reached the primary endpoint within 24 weeks with a 20 percent response from the American Rheumatology Society (ACR). During the trial, Filgotinib was evaluating adamo monoantigen or placebo. We are studying this drug as a potential treatment for adult patients with moderate to severe active rheumatoid arthritis.

finch 1 and FINCH 3 studies have shown that filgotinib is consistent with previous studies.

Gilead said in a statement this morning about the new drug approval application that it also discussed the second phase of the MANTA study, which used filgotinib to evaluate semen parameters in men with moderate to severe active ulcerative colitis or Crohn's disease. However, the company did not provide any other updates on the trial. It merely points out that there is still some way to go before there is a potential regulatory review of the filgotinib for rheumatoid arthritis. (Compiled by this web)