The Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Gilead Sciences related to the New Drug Application (NDA) for filgotinib in the treatment of moderately to severely active rheumatoid arthritis (RA).

In the CRL, the Agency requested that the Company provide data from the MANTA and MANTA-RAy studies before the review is completed. These studies were designed to evaluate the effect of filgotinib, an investigational oral selective Janus kinase (JAK)1 inhibitor, on sperm parameters. Additionally, the Agency relayed concerns regarding the overall benefit/risk profile of the 200mg dose.

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The NDA, which was submitted for Priority Review in December 2019, includes data from the phase 3 FINCH clinical program, which evaluated the safety and efficacy of filgotinib in over 3000 patients with moderate to severe RA. “We are disappointed in this outcome and will evaluate the points raised in the CRL for discussion with the FDA,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “We continue to believe in the benefit/risk profile of filgotinib in RA, which has been demonstrated in the FINCH phase 3 clinical program.”

Data regarding the long-term safety of filgotinib in RA were recently presented at the European League Against Rheumatism (EULAR) European E-Congress of Rheumatology 2020. Results showed that across 7 studies, the treatment was found to be well tolerated with no clinically meaningful dose-dependent safety effects.

Topline data from the MANTA and MANTA-RAy studies are expected in the first half of 2021. 

For more information visit gilead.com.

References

  1. Gilead receives complete response letter for filgotinib for the treatment of moderately to severely active rheumatoid arthritis. https://www.businesswire.com/news/home/20200818005811/en/Gilead-Receives-Complete-Response-Letter-Filgotinib-Treatment. Accessed August 19, 2020.
  2. Genovese, M C et al. Integrated safety analysis of filgotinib treatment for rheumatoid arthritis from 7 clinical trials. Poster#0202 at the European League Against Rheumatism, EULAR, European E-Congress of Rheumatology 2020.