The rheumatic drug filgotinib from the Belgian-Dutch pharmaceutical company Galapagos has not yet received the green light from the US Food and Drug Administration (FDA). The company, with headquarters in Mechelen, announced this on Wednesday morning.
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For sales in the US, Galapagos closed a multi-billion dollar deal last year with US pharmaceutical company Gilead, which is also the company behind covid inhibitor inhibdesivir. Gilead now received a “very disappointing” response from the FDA. The letter indicates that the application review has been completed, but the application is not ready for approval in its current form.
The FDA has requested the data from the MANTA and MANTA-RAy studies before finalizing the review. The MANTA and MANTA-RAy studies were designed to determine whether filgotinib has an impact on sperm parameters. The FDA has also raised concerns about the overall benefit-risk profile of the filgotinib 200mg dose.
‘Disappointed’
“We are disappointed with this outcome and will review the points outlined in the CRL for discussion with the FDA,” said Gilead’s Merdad Parsey. “Despite today’s news, we continue to believe that filgotinib has the potential to become an effective new treatment option for patients with rheumatoid arthritis, an area of disease where there is still a significant unmet medical need.” said Dr. Walid Abi-Saab from Galapagos.
Filgotinib is a drug candidate for adults with moderate to severe rheumatism. At the end of July, the pharmaceutical company already took a major hurdle in Europe, when the European Medicines Agency (EMA) issued a positive advice on the drug. That advice has now been sent to the European Commission, which will evaluate the recommendation with a view to final approval to market the drug. Galapagos and Gilead expect that decision in the third quarter.
billion Deal
In the summer of 2019, Galapagos announced a billion dollar deal with Gilead. The Americans are paying $ 3.95 billion for access to Galapagos’ drugs under development and are investing $ 1.1 billion in stocks. Gilead also agreed not to make a takeover bid for the company in the next ten years. Several years earlier, Gilead had already paid hundreds of millions to Galapagos in exchange for the US rights to sell the drug.
The deal with Gilead also provided for a $ 100 million milestone payment if the drug is approved in the US. That was included in Galapagos’ expectations. As a result of the FDA response, Galapagos is revising its operational cash burn forecast for 2020 to EUR 490-520 million.
The sale of medicines against rheumatism is by far the largest pharmaceutical market.
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