We are pleased to announce that we have agreed with Gilead a much-improved European marketing and commercialization agreement for Jyseleca (filgotinib), with Galapagos assuming full responsibility across Europe for all indications of filgotinib. This is aligned to the European commercial future strategy and vision for Galapagos.
This new agreement has been made following feedback from the US Food and Drug Administration (FDA), received by Gilead during a Type A meeting, to discuss the complete response letter (CRL) received earlier this year in response to the filgotinib new drug application (NDA) in rheumatoid arthritis (RA). Gilead now believes the 200 mg dose is unlikely to achieve FDA approval in RA, so they have taken the decision not to launch in this indication in the U.S.
We are very disappointed in the FDA’s feedback as we firmly believe in the clinical profile of filgotinib, which has been recognized by regulatory authorities in Europe and Japan. It is, however, a twist of fate that the unexpected FDA setback offers a great opportunity for us: the revised agreement considerably accelerates our plan to take full responsibility for commercialization across the European region, aligning with the collaboration agreement for future potential products, such as ziritaxestat in IPF.
Clearly there is much now for us to do. Through a phased transition period from Gilead, the majority of activities supporting filgotinib in Europe are expected to be assumed by Galapagos by the end of 2021. We have made tremendous progress in building our Galapagos European commercial organization and in preparing successful launches for filgotinib in RA. Importantly, both companies remain committed to our long-term collaboration to discover and develop new therapies for inflammatory diseases, fibrosis and beyond.
It can’t be denied that 2020 was a difficult year, but together with my team, Gilead, our stakeholders and investors, I am looking forward to this new chapter in the history of Galapagos.