Filgotinib

Gilead and Galapagos Announce Filgotinib Meets Primary Endpoint in the Phase 3 FINCH 3 Study in Methotrexate-Naïve Rheumatoid Arthritis Patients

Retrieved on: 
Thursday, March 28, 2019
Health, Biotechnology, Clinical trials, Hospitals, Infectious diseases, Pharmaceutical, Filgotinib, MTX

Serious infections occurred in 1.0 percent, 1.0 percent, 1.4 percent and 1.0 percent of the patients in the filgotinib 200 mg plus MTX, filgotinib 100 mg plus MTX, filgotinib 200 mg monotherapy and MTX groups, respectively.

Key Points: 
  • Serious infections occurred in 1.0 percent, 1.0 percent, 1.4 percent and 1.0 percent of the patients in the filgotinib 200 mg plus MTX, filgotinib 100 mg plus MTX, filgotinib 200 mg monotherapy and MTX groups, respectively.
  • These data add to the body of evidence from our broader FINCH clinical study program, reinforcing the potential for filgotinib to address important therapeutic needs in people with rheumatoid arthritis.
  • Patients were randomized (2:1:1:2) to receive filgotinib 200 mg plus MTX (n=417), filgotinib 100 mg plus MTX (n=207), filgotinib 200 mg alone (n=210) or MTX (n=418).
  • 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 Announce Filgotinib Meets Primary and Key Secondary Endpoints in the Phase 3 FINCH 1 Rheumatoid Arthritis Study

Retrieved on: 
Thursday, March 28, 2019
Health, Biotechnology, Clinical trials, Hospitals, Pharmaceutical, Medical specialties, RTT, Medicine, Filgotinib, Clinical medicine, Arthritis, Rheumatoid arthritis, Forward-looking statement

The safety profile of filgotinib in FINCH 1 is consistent with prior studies up to Week 24.

Key Points: 
  • The safety profile of filgotinib in FINCH 1 is consistent with prior studies up to Week 24.
  • Many patients living with rheumatoid arthritis are in need of new treatment options that are effective, well-tolerated, and convenient.
  • We are excited about the strong efficacy and tolerability results with both doses of filgotinib, said Dr.Walid Abi-Saab, Chief Medical Officer, Galapagos.
  • 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 Report Updated Safety Information for Filgotinib in Rheumatoid Arthritis (RA)

Retrieved on: 
Thursday, March 28, 2019
Health, Biotechnology, Clinical trials, Hospitals, Infectious diseases, Pharmaceutical, Filgotinib, Biotechnology, Gilead Sciences, Life sciences, MTX, Gilead, Forward-looking statement, Articles

FINCH 3 is a 52-week, randomized trial in 1,252 MTX-nave patients to study filgotinib in combination with MTX, as well as monotherapy.

Key Points: 
  • FINCH 3 is a 52-week, randomized trial in 1,252 MTX-nave patients to study filgotinib in combination with MTX, as well as monotherapy.
  • Galapagos and Gilead entered into a global collaboration for the development and commercialization of filgotinib in inflammatory indications.
  • Gilead Sciences, Inc.is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need.
  • All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

Global Rheumatoid Arthritis Competitor Landscape Report 2018-2019YE

Retrieved on: 
Monday, February 4, 2019
Medical specialties, Medicine, Immunology, RTT, Immunosuppressants, Arthritis, Autoimmune diseases, Monoclonal antibodies, Filgotinib, Rheumatoid arthritis, Abatacept, Baricitinib

The "Competitor Landscape: Rheumatoid Arthritis" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Competitor Landscape: Rheumatoid Arthritis" report has been added to ResearchAndMarkets.com's offering.
  • "Competitor Landscape: Rheumatoid Arthritis", briefings contain evaluations of ongoing development activities within the Rheumatoid Arthritis (RA) disease market, together with analysis of current & potential future product positioning.
  • If the results of the Phase II MANTA safety trial are required by the FDA prior to filing for regulatory approval of filgotinib for Rheumatoid Arthritis (RA), this could delay US approval by 2 years.
  • The Phase II trial assessing the immunogenicity and safety of Zostavax in Rheumatoid Arthritis (RA) patients using abatacept, if positive, is likely to boost physician opinion of abatacept's safety profile in Rheumatoid Arthritis (RA), and reduce potential physician concerns that the use of abatacept may negatively impact the effectiveness of some immunizations, as suggested by its US FDA label.

AbbVie's Upadacitinib Shows Significant Improvements in Physical Function, Pain and Quality of Life as a Monotherapy in Patients with Rheumatoid Arthritis in Phase 3 Patient-Reported Outcomes Data

Retrieved on: 
Tuesday, October 23, 2018
Medicine, RTT, Immunology, Clinical medicine, Arthritis, Anti-inflammatory agents, Rheumatology, Upadacitinib, Rheumatoid arthritis, Tocilizumab, Filgotinib

"Upadacitinib as a monotherapy showed significant improvements in rheumatoid arthritis patients' ability to perform daily activities and overall health-related quality of life," saidMarek Honczarenko, M.D., Ph.D., vice president, global immunology development, AbbVie.

Key Points: 
  • "Upadacitinib as a monotherapy showed significant improvements in rheumatoid arthritis patients' ability to perform daily activities and overall health-related quality of life," saidMarek Honczarenko, M.D., Ph.D., vice president, global immunology development, AbbVie.
  • "These results show that the improvements in clinical symptoms are accompanied by improvement in outcomes important to patients.
  • These results reinforce upadacitinib's therapeutic potential across diverse rheumatoid arthritis patient populations and its use as a monotherapy treatment option."
  • The robust SELECT Phase 3 rheumatoid arthritis program evaluates more than 4,000 patients with moderate to severe rheumatoid arthritis in six studies.