Just lucky schreef op 12 juli 2020 16:22:
Net door Alpen gepost op het filgotinib draadje.
FWIW heb ik, n.a.v. de CHMP meeting highlights van mei en de CHMP agenda van juni, de EMA in juni een mail gestuurd:
I have a question regarding the CHMP agenda and minutes of last month, May 2020, and the CHMP agenda of this month related to handling of filgotinib - EMEA/H/C/005113.
The explanatory notes in agenda’s chapter 16 state that:
a) “Section 3.1 is for medicinal products nearing the end of the evaluation and for which the CHMP is expected to adopt an opinion at this meeting on whether marketing authorisation should be granted.”
b) “CHMP discussions on products that have received a CHMP opinion and are awaiting a decision are listed under section 3.6, products in the decision making phase”
The May agenda shows in section 3.1, more specifically in 3.1.2: “filgotinib - EMEA/H/C/005113”, having as Scope: “Opinion” and Action: “For adoption”.
However, the related May 2020 meeting highlights do not refer to it, nor does this product appear in section 3.6 (or any other section) of the June agenda. It just “seems to have vanished”.
My assumption is therefore that filgotinib was correctly, as planned, included in section 3.1 of the May agenda and the CHMP effectively adopted an opinion for it, but results were intentionally not disclosed due to reasons of commercial confidentiality or sensitivity, as mentioned in the disclaimer of the agenda.
Is my assumption correct?
Enkele dagen geleden het volgende antwoord gekregen:
Thank you for contacting the European Medicines Agency (EMA) regarding filgotinib.
We can confirm that filgotinib was discussed at the May 2020 CHMP meeting, but a conclusion as to whether to recommend this medicine for a marketing authorisation was not reached. We do expect the evaluation of filgotinib to conclude relatively soon but are unable to be more specific as it depends on the discussions between the Agency’s scientific committees and the company.
Once the evaluation is completed, EMA will publish the outcome in the CHMP meeting highlights. Even if the application should be successful, it may be some time before the medicine becomes available for patients.