So, what led the FDA to be so highly suspicious remains a mystery? Did Galapagos and Gilead provide all the data to the FDA? Or is this just another FDA U-turn that the agency can be used to do in some reviews? Also, why not approving the 100mg dose? And finally, the safety profile of the 100mg and the 200mg doses, according to the reported data, really seems similar, even for each individual adverse events of special interest. The EMA approved the dossier but obviously, this is in the to-do list of Galapagos to submit any new relevant data to the EMA. There is also no explanation on why filgotinib would cause such an issue (it is apparently molecule specific, and not pathway specific). For sure, the message in the EMA “EPAR” evaluation dossier indicate some potential negative effects in rodents, and the durability was not clear. ![]() Finally, the FDA seemingly changed their mind during the review of the dossier, and even raised the bar in their last meeting with the applicants: they indeed requested a longer follow-up to check the reversibility of any potential negative effect on spermatogenesis, delaying the final outcome by at least 6 months. Given that the timing aspect was also critical not to let Rinvoq take a too strong lead, Gilead and Galapagos understood they could file without having the MANTA/MANTA-Ray studies completed (note that the wording does not say that no data at all would be needed during the review, but just indicates that the dossier could be submitted without having the data in hands at the time of the submission). But timing-wise, these trials were in the critical path for the US dossier in RA. As a reminder, the original plan was indeed to integrate the data from these studies in the US dossier. The CEO of Galapagos indicated that the FDA provided no reason on why they changed their mind on the need to see the data from the MANTA/MANTA-Ray studies. recently in UC, where the results seem to indicate a better efficacy than filgotinib). Obviously, the ambitions for filgotinib were reviewed down by the market, by much, while AbbVie’s upadacitinib (Rinvoq) continues to generate positive data in other indications (e.g. ![]() Except that he meant more for a longer period than just a few days or weeks.Īfter a new meeting with the FDA to address the agency’s concerns, the position of the FDA did not change at all, according to Onno van de Stole, leading Gilead to abandon the idea of marketing filgotinib in RA in the US, and more generally to the reshaping of the licensing deal for filgotinib. Galapagos even transiently became the largest European public biotech company ahead of Genmab, which was the dream of its CEO, Onno van de Stolpe. Just 13 months ago, on July 14th, 2019, the Belgian-American couple had sealed an historical long-term strategic alliance for a decade, with a 4 bUSD / 3.5 bEUR upfront, another equity investment of 1.5 bUSD / 1.3b EUR, and a total deal value of 7.7 bUSD / 6.8 bEUR. ![]() In their CRL, the FDA expressed concerns on the benefit/risk profile of the 200 mg dose (a key point of differentiation), and after a surprising statement that the agency could not complete the review without having more data from the ongoing male testicular safety study (MANTA/MANTA-Ray trials). What were the odds? For those who followed the saga of filgotinib application in RA in the US (and the Galapagos investors among them), this is the question they may have asked themselves, after the CRL issued by the FDA in August 2020 to Gilead and Galapagos. May 29th, 1999, Manchester United defeats the Bayern Munich in the finals of the UEFA Champion’s League, scoring twice in the extra-time and winning 2-1, after having been led since the 6th minute.
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