Filgotinib

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) < 2.6.
  • 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.

GILEAD AND GALAPAGOS ANNOUNCE EFFICACY AND SAFETY RESULTS OF FILGOTINIB THROUGH 52 WEEKS IN FINCH 1 AND FINCH 3 STUDIES IN RHEUMATOID ARTHRITIS

Thursday, October 10, 2019 - 11:00pm

These data suggest that filgotinib if approved, may play an important role in helping people living with rheumatoid arthritis achieve sustained, clinically meaningful responses.

Key Points: 
  • These data suggest that filgotinib if approved, may play an important role in helping people living with rheumatoid arthritis achieve sustained, clinically meaningful responses.
  • Detailed Week 52 results from the FINCH 1 and 3 trials will be submitted for presentation at a future medical conference.
  • Gilead plans to file a New Drug Application (NDA) for filgotinib for the treatment of rheumatoid arthritis in the United States including the FINCH 1 and FINCH 3 Week 52 data later this year.
  • 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 Efficacy and Safety Results of Filgotinib Through 52 Weeks in FINCH 1 and FINCH 3 Studies in Rheumatoid Arthritis

Thursday, October 10, 2019 - 11:00pm

These data suggest that filgotinib if approved, may play an important role in helping people living with rheumatoid arthritis achieve sustained, clinically meaningful responses.

Key Points: 
  • These data suggest that filgotinib if approved, may play an important role in helping people living with rheumatoid arthritis achieve sustained, clinically meaningful responses.
  • Detailed Week 52 results from the FINCH 1 and 3 trials will be submitted for presentation at a future medical conference.
  • Gilead plans to file a New Drug Application (NDA) for filgotinib for the treatment of rheumatoid arthritis in the United States including the FINCH 1 and FINCH 3 Week 52 data later this year.
  • All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

EUROPEAN MEDICINES AGENCY VALIDATES MARKETING APPLICATION FOR FILGOTINIB FOR THE TREATMENT OF RHEUMATOID ARTHRITIS

Thursday, August 15, 2019 - 9:01pm

Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements.

Key Points: 
  • Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements.
  • Further, there is the possibility of unfavorable results from ongoing and additional clinical trials involving filgotinib.
  • These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements.
  • All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

European Medicines Agency Validates Marketing Application for Filgotinib for the Treatment of Rheumatoid Arthritis

Thursday, August 15, 2019 - 9:01pm

Gilead Sciences, Inc. (NASDAQ: GILD) and Galapagos NV (Euronext & NASDAQ: GLPG) today announced that the Marketing Authorization Application (MAA) for filgotinib, an investigational, oral, selective JAK1 inhibitor, for the treatment of adults with rheumatoid arthritis (RA) has been validated and is now under evaluation by the European Medicines Agency (EMA).

Key Points: 
  • Gilead Sciences, Inc. (NASDAQ: GILD) and Galapagos NV (Euronext & NASDAQ: GLPG) today announced that the Marketing Authorization Application (MAA) for filgotinib, an investigational, oral, selective JAK1 inhibitor, for the treatment of adults with rheumatoid arthritis (RA) has been validated and is now under evaluation by the European Medicines Agency (EMA).
  • The filgotinib filing will be reviewed by the EMA under the centralized licensing procedure for all 28 member states of the European Union, as well as Norway, Iceland and Liechtenstein.
  • In early July, Gilead announced plans to submit a New Drug Application (NDA) for filgotinib for the treatment of RA in the United States before the end of the year.
  • Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need.

Gilead Announces Intent to Submit New Drug Application for Filgotinib to U.S. Food and Drug Administration This Year

Tuesday, July 2, 2019 - 12:00am

As a result of this discussion, a path forward has been established to submit the NDA for filgotinib as a treatment for rheumatoid arthritis in 2019.

Key Points: 
  • As a result of this discussion, a path forward has been established to submit the NDA for filgotinib as a treatment for rheumatoid arthritis in 2019.
  • 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.
  • For more information about Gilead, please visit the companys website at www.gilead.com , follow Gilead on Twitter (@Gilead Sciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

New Long-Term Data from Upadacitinib Phase 3 Studies in Rheumatoid Arthritis Including Results on Clinical Remission at 48 Weeks Presented at EULAR

Wednesday, June 12, 2019 - 11:00pm

The robust SELECT Phase 3 rheumatoid arthritis program evaluates more than 4,900 patients with moderately to severely activerheumatoid arthritis in six studies.

Key Points: 
  • The robust SELECT Phase 3 rheumatoid arthritis program evaluates more than 4,900 patients with moderately to severely activerheumatoid arthritis in six studies.
  • Monotherapy with Upadacitinib in MTX-nave Patients with Rheumatoid Arthritis: Results at 48 Weeks from the SELECT-EARLY Study.
  • Safety and Effectiveness of Upadacitinib or Adalimumab in Patients with Rheumatoid Arthritis: Results at 48 weeks from the SELECT-COMPARE Study.
  • Safety profile of upadacitinib in Rheumatoid Arthritis: Integrated analysis from the SELECT Phase 3 Clinical Program.