Gilead Sciences and Galapagos NV announced that the companies have agreed to amend their existing arrangement for the commercialisation and development of Jyseleca (filgotinib). This announcement follows a Type A meeting with the US Food and Drug Administration (FDA) to discuss the points raised in the Complete Response Letter (CRL) related to the New Drug Application (NDA) for filgotinib in the treatment of Rheumatoid Arthritis (RA).
Based on the feedback received from the FDA during the NDA review process and in the Type A meeting, Gilead will not pursue FDA approval of filgotinib for RA. Gilead has concluded that this dose is required to be competitive in RA in the US and that the 200 mg dose is unlikely to achieve approval for RA in the US without conducting substantial additional clinical studies.
Under the new arrangement between the companies, Galapagos will assume sole responsibility in Europe for filgotinib in RA, where 200 mg and 100 mg doses are approved for the treatment of moderate to severe RA, and in all future indications. Galapagos will receive payments from Gilead in connection with changes in responsibility for the commercialisation and development of filgotinib in Europe and Gilead will receive royalties from European sales of filgotinib. This is an acceleration of the commercial strategy in place for products under the separate ten-year research and development collaboration between the companies, where Galapagos is also responsible for European commercialisation.
Through a phased transition including the transfer of filgotinib’s marketing authorisation to Galapagos, the majority of activities supporting filgotinib in Europe are expected to be assumed by Galapagos by the end of 2021. Under the new operating model, Gilead will retain commercial rights and remain marketing authorisation holder for filgotinib outside of Europe, including in Japan where filgotinib has recently been approved and is co-marketed with Eisai.
“While we believe that the clinical profile of Jyseleca could help many patients living with RA, we no longer see a viable path to US approval in this indication. In this new context, Gilead and Galapagos believe it makes sense for Galapagos to drive commercialisation in Europe,” said Daniel O’Day, Chairman and Chief Executive Officer, Gilead Sciences.
Onno van de Stolpe, CEO of Galapagos said, “While we are very disappointed by the outcome of the FDA meeting, we are excited that we can now accelerate the plan for Galapagos to lead on commercial activities in Europe in our ongoing collaboration with Gilead, and fully leverage the commercial organisation Galapagos has built for the Jyseleca launch.”