Filgotinib

Gilead and Galapagos Announce Positive Topline Results of Phase 2b/3 Trial of Filgotinib in Moderately to Severely Active Ulcerative Colitis

Wednesday, May 20, 2020 - 9:03pm

Of patients receiving filgotinib 100 mg, 23.8 percent achieved clinical remission at Week 58, compared with 13.5 percent treated with placebo (p=0.0420).

Key Points: 
  • Of patients receiving filgotinib 100 mg, 23.8 percent achieved clinical remission at Week 58, compared with 13.5 percent treated with placebo (p=0.0420).
  • The SELECTION Phase 2b/3 trial is a multi-center, randomized, double-blind, placebo-controlled trial to assess the safety and efficacy of the selective JAK1 inhibitor filgotinib in adult patients with moderately to severely active ulcerative colitis.
  • Across both induction studies, patients with moderately to severely active UC were randomized to receive filgotinib 200 mg, filgotinib 100 mg or placebo in a 2:2:1 ratio.
  • Gilead and Galapagos NV are collaborative partners in the global development and commercialization of filgotinib in inflammatory indications.

GILEAD AND GALAPAGOS ANNOUNCE POSITIVE TOPLINE RESULTS OF PHASE 2B/3 TRIAL OF FILGOTINIB IN MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS

Wednesday, May 20, 2020 - 8:21pm

Of patients receiving filgotinib 100 mg, 23.8 percent achieved clinical remission at Week 58, compared with 13.5 percent treated with placebo (p=0.0420).

Key Points: 
  • Of patients receiving filgotinib 100 mg, 23.8 percent achieved clinical remission at Week 58, compared with 13.5 percent treated with placebo (p=0.0420).
  • The SELECTION Phase 2b/3 trial is a multi-center, randomized, double-blind, placebo-controlled trial to assess the safety and efficacy of the selective JAK1 inhibitor filgotinib in adult patients with moderately to severely active ulcerative colitis.
  • Across both induction studies, patients with moderately to severely active UC were randomized to receive filgotinib 200 mg, filgotinib 100 mg or placebo in a 2:2:1 ratio.
  • Gilead and Galapagos are collaborative partners in the global development and commercialization of filgotinib in inflammatory indications.

Gilead and Eisai Enter Into Agreement in Japan for the Co-Promotion of the Investigational Rheumatoid Arthritis Therapy Filgotinib, Pending Regulatory Approval

Tuesday, December 24, 2019 - 6:00am

(Tokyo, Japan) and Eisai have entered into an agreement for the distribution and co-promotion of filgotinib, an investigational, oral, selective JAK1 inhibitor, in Japan, pending regulatory approval for the treatment of rheumatoid arthritis (RA).

Key Points: 
  • (Tokyo, Japan) and Eisai have entered into an agreement for the distribution and co-promotion of filgotinib, an investigational, oral, selective JAK1 inhibitor, in Japan, pending regulatory approval for the treatment of rheumatoid arthritis (RA).
  • Through this collaboration, Gilead Japan will retain responsibility for manufacturing and marketing approval of filgotinib, while Eisai will be responsible for product distribution in Japan in RA and other potential future indications.
  • Filgotinib is pending regulatory approval in Japan, Europe and the United States, based on global Phase 3 trials evaluating its efficacy and tolerability.
  • All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

Gilead submits new drug application to U.S. Food and Drug Administration under priority review for filgotinib for rheumatoid arthritis treatment

Thursday, December 19, 2019 - 9:30pm

A priority review voucher was submitted with the NDA, shortening the anticipated time for review.

Key Points: 
  • A priority review voucher was submitted with the NDA, shortening the anticipated time for review.
  • Safety results were consistent across the trials and further reinforce the long-term safety and tolerability profile of filgotinib for a broad range of RA patients.
  • As part of the collaboration terms, upon NDA submission, Galapagos receives a $20 million milestone payment from Gilead.
  • Gilead and Galapagos are collaborative partners in the global development and commercialization of filgotinib in RA, and other potential inflammatory indications.

Gilead Submits Filgotinib New Drug Application to U.S. Food and Drug Administration Under Priority Review for Rheumatoid Arthritis Treatment

Thursday, December 19, 2019 - 9:30pm

A priority review voucher was submitted with the NDA, shortening the anticipated time for review.

Key Points: 
  • A priority review voucher was submitted with the NDA, shortening the anticipated time for review.
  • One in five patients do not achieve complete disease remission during their lifetimes and remain in need of treatment options.
  • In the United States, Gilead is solely responsible for the commercialization of filgotinib, pending approval of filgotinib by the FDA.
  • All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

Promising Early Launch Metrics for AbbVie's Rinvoq (upadacitinib) to Help JAK Inhibitors Solidify Their Position as Second-Line Leaders in Rheumatoid Arthritis, According to Spherix Global Insights

Monday, December 16, 2019 - 7:14pm

By comparison, Olumiant and Kevzara garnered a user-base of only 4% and 25%, respectively, at a similar time period post-launch.

Key Points: 
  • By comparison, Olumiant and Kevzara garnered a user-base of only 4% and 25%, respectively, at a similar time period post-launch.
  • Other brands anticipated to grow include Kevzara and Olumiant (though to a much lesser extent), while Xeljanz remains relatively flat.
  • With Rinvoq out of the pipeline picture, rheumatologists are more likely to prefer Gilead/Galapagos' filgotinib (JAK) and Merck's evobrutinib (BTK) over other developmental agents.
  • Spherix will continue to track the launch of Rinvoq over the next year.

NEW DATA ON FILGOTINIB IN RHEUMATOID ARTHRITIS (RA) DEMONSTRATE DURABLE EFFICACY AND SAFETY PROFILE

Saturday, November 9, 2019 - 9:30pm

The data demonstrate durable efficacy and safety results with filgotinib across multiple RA patient populations, from MTX-nave patients to those who have had an inadequate response to two or more biologic disease-modifying anti-rheumatic drugs (bDMARDs).

Key Points: 
  • The data demonstrate durable efficacy and safety results with filgotinib across multiple RA patient populations, from MTX-nave patients to those who have had an inadequate response to two or more biologic disease-modifying anti-rheumatic drugs (bDMARDs).
  • Filgotinib efficacy was measured by ACR20, and Disease Activity Score 28 (DAS28(CRP)) 3.2 and DAS28(CRP)
  • Results demonstrate that, compared with placebo, filgotinib consistently improved clinical outcomes in bDMARD-IR patients and that treatment efficacy was not impacted by any of these demographic and clinical baseline characteristics.
  • Data comprising 2,203 patient-years of exposure (PYE) with filgotinib from the Phase 2b, open-label extension DARWIN 3 study assessed the long-term safety and efficacy of filgotinib (200 mg or 100 mg) monotherapy and filgotinib plus MTX in 739 patients.

New Data on Filgotinib in Rheumatoid Arthritis (RA) Demonstrate Durable Efficacy and Safety Profile

Saturday, November 9, 2019 - 9:30pm

The data demonstrate durable efficacy and safety results with filgotinib across multiple RA patient populations, from MTX-nave patients to those who have had an inadequate response to two or more biologic disease-modifying antirheumatic drugs (bDMARDs).

Key Points: 
  • The data demonstrate durable efficacy and safety results with filgotinib across multiple RA patient populations, from MTX-nave patients to those who have had an inadequate response to two or more biologic disease-modifying antirheumatic drugs (bDMARDs).
  • Results demonstrate that, compared with placebo, filgotinib consistently improved clinical outcomes in bDMARD-IR patients and that treatment efficacy was not impacted by any of these demographic and clinical baseline characteristics.
  • Data comprising 2,203 patient-years of exposure (PYE) with filgotinib from the Phase 2b, open-label extension DARWIN 3 study assessed the long-term safety and efficacy of filgotinib (200 mg or 100 mg) monotherapy and filgotinib plus MTX in 739 patients.
  • Serious TEAEs occurred in 13.6 percent (n=33) of the filgotinib monotherapy group and 9.1 percent (n=45) of the filgotinib plus MTX group.

GILEAD AND GALAPAGOS TO PRESENT NEW DATA ON FILGOTINIB AT 2019 ACR/ARP ANNUAL MEETING

Thursday, October 31, 2019 - 8:01pm

We are proud to share these latest data at the 2019 ACR/ARP Annual Meeting, said Dr. Walid Abi-Saab, Chief Medical Officer, Galapagos.

Key Points: 
  • We are proud to share these latest data at the 2019 ACR/ARP Annual Meeting, said Dr. Walid Abi-Saab, Chief Medical Officer, Galapagos.
  • Presented data will assess the relationship between a series of RA biomarkers and the therapeutic response of filgotinib.
  • For more information, including a complete list of the abstracts being presented at the 2019 ACR/ARP annual meeting, please visit: https://acrabstracts.org .
  • All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

Gilead and Galapagos to Present New Data on Filgotinib at 2019 ACR/ARP Annual Meeting

Thursday, October 31, 2019 - 8:01pm

We are proud to share these latest data at the 2019 ACR/ARP Annual Meeting, said Dr. Walid Abi-Saab, Chief Medical Officer, Galapagos.

Key Points: 
  • We are proud to share these latest data at the 2019 ACR/ARP Annual Meeting, said Dr. Walid Abi-Saab, Chief Medical Officer, Galapagos.
  • Presented data will assess the relationship between a series of RA biomarkers and the therapeutic response of filgotinib.
  • For more information, including a complete list of the abstracts being presented at the 2019 ACR/ARP annual meeting, please visit: https://acrabstracts.org .
  • All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.