beagle06 schreef op 19 augustus 2020 01:33:
Beste IEX leden,
Less than a month after the positive CHMP opinion, we have received a complete response letter from the FDA for filgotinib. With this letter the FDA indicates that it has finished the review of the data submitted and cannot approve the application in its current form. You can find the press release on the CRL here.
While this is very disappointing and an unexpected setback, we strongly believe in the strength of our data and remain confident in the positive risk/benefit profile of filgotinib.
The FDA has requested data from the MANTA and MANTA-RAy studies before completing its review of the NDA. The FDA also expressed concerns regarding the overall benefit/risk profile of the filgotinib 200 mg dose. Gilead, who is the market authorization holder, intends to meet with the FDA to discuss the CRL and determine the next steps. Approval of filgotinib for the US market continues to remain our goal.
Personally, I’m extremely disappointed by the FDA decision, which I find hard to understand and accept given the clinical trial data, which already led to a recommendation for approval in Europe. We all know the science behind filgotinib is solid and we believe that the safety data underline the differentiated profile of filgotinib.
As I find it important to communicate in an open and transparent way about this decision to our stakeholders, I have written a blog which you can find on the homepage of
www.glpg.com.On the positive side, the fundamentals of our company are and remain strong: we have a deep pipeline, a lot of cash available to develop it, an ambitious strategy and we have the best people on board. So, let’s take this in our stride and focus on achieving our other goals. I’m looking forward to a successful launch in Europe, while we work on addressing the FDA issue.
Please do not hesitate to reach out to Elizabeth, Sofie, Bart or myself if you would like to discuss the situation. We thank you for your believe in, and support of, Galapagos and I hope you remain a shareholder in the exciting times to come.
Enorm balen en teleurstellend,,,,,,,,,,,,,,, Ik had graag beter nieuws hier geplaatst.
Onno
Onno van de Stolpe
CEO
Galapagos