FDA Issues Gilead Complete Response Letter for Arthritis Drug
Gilead Sciences has been issued a Complete Response Letter (CRL) by the US Food and Drug Administration (FDA) for its new drug application (NDA) for filgotinib, an investigational drug for treating moderately to severely active rheumatoid arthritis. The drug had been projected by some analysts as a potential blockbuster.
The FDA expressed concerns regarding the overall benefit/risk profile of the filgotinib 200-mg dose. In addition, the FDA has requested additional data from two clinical studies that are designed to assess whether filgotinib has an impact on sperm parameters before completing its review of the NDA. These studies are fully recruited, with topline results anticipated in the first half of 2021.
Filgotinib is projected by some analysts as a potential blockbuster. If approved, the drug would compete against other drugs to treat rheumatoid arthritis with different mechanisms of action, such as AbbVie’s Humira (adalimumab), Bristol-Myers Squibb’s Orencia (abatacept), Sobi’s Kineret (anakinra), Sanofi’s and Regeneron’s Kevzara (sarilumab), Roche’s Actemra (tocilizumab), and Roche’s/Biogen’s Rituxan (rituximab) as well as multiple other JAK inhibitors, including Pfizer’s Xeljanz (tofacitinib), Eli Lilly and Company’s Olumiant (baricitinib), and AbbVie’s Rinvoq (upadacitinib).
Filgotinib recently received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use, which recommended marketing authorization for filgotinib in the European Union for treating adults with moderate-to-severe rheumatoid arthritis, who have responded inadequately or are intolerant of one or more disease-modifying anti-rheumatic drugs.
Gilead and Galapagos, a Mechelen, Belgium-based pharmaceutical company, are collaborative partners in the global development and commercialization of filgotinib in rheumatoid arthritis and other inflammatory indications. In 2019, the companies entered into a global 10-year R&D collaboration, worth up to $5 billion, including a $3.95-billion upfront licensing fee by Gilead to Galapagos. Under that deal, Gilead gained access to a portfolio of compounds, including six molecules in clinical trials, more than 20 preclinical programs, a drug-discovery platform, and rights to GLPG1690, Galapagos’ Phase III candidate for treating idiopathic pulmonary fibrosis. The deal also amended certain terms governing filgotinib to provide a broader commercialization role for Galapagos in Europe. Gilead is the market authorization holder for filgotinib in the US and is responsible for potential commercialization in the US.