Gilead Sciences Inc and Galapagos NV have dropped plans to make a new submission in the US for their small molecule drug Jyseleca (filgotinib) in rheumatoid arthritis (RA) following a meeting with the Food and Drug Administration. The parties discussed the points raised in the agency’s complete response letter in August in which it refused to approve the drug because of concerns about its benefit/risk profile at a dose of 200 mg.
“While both Gilead and Galapagos continue to believe in the clinical profile of the 200 mg dose, Gilead has concluded that this dose is required to be competitive in RA in the United States and that the 200 mg dose is unlikely to achieve approval for RA in the US without conducting substantial additional clinical trials,” according to a statement issued by the companies on 15 December.
Jyseleca is a JAK1 inhibitor, designed to block the activity of one of the Janus kinase family of enzymes and stop cytokine signalling. Galapagos discovered the drug, and the two companies have been collaborating on its development since 2015. In July of 2019, Gilead struck a $5 billion deal with Galapagos to commercialise filgotinib and other small molecule drugs for inflammatory diseases in the Belgian company’s portfolio.
The FDA’s complete response letter in August was unexpected, and raised the threshold for approval. The agency asked for data from two ongoing male safety studies and cited concerns about the 200 mg dose. By contrast in July, the European Medicines Agency had given the drug a positive opinion at both 100 mg and 200 mg doses. In September, the European Commission followed the advice of the EMA and approved the drug at both doses. The Japanese regulator did the same.
In their joint announcement on 15 December, Gilead and Galapagos said they will discontinue the global development programme for filgotinib in psoriatic arthritis, ankylosing spondylitis and non-infectious uveitis in the absence of a viable path forward in the US. However the companies will continue to investigate the drug for patients with inflammatory bowel disease (IBD). Galapagos will be in charge of trials in ulcerative colitis and Gilead, for trials in Crohn’s disease. The EMA is currently reviewing filgotinib in ulcerative colitis. An application in Japan is expected in the same indication during the first half of 2021. A US filing for filgotinib in IBD is not excluded pending data from the male safety studies.
Given the changes in regulatory strategy, Gilead and Galapagos have revised their collaboration agreement. Going forward, Galapagos will be responsible for the commercialisation of filgotinib in Europe and pay royalties to Gilead starting in 2024. Gilead will not make milestone payments for the product in Europe. The US company will however pay Galapagos €160 million to support the ongoing development and commercialisation of filgotinib in Europe.
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