Aandeel Galapagos AEX:GLPG.NL, BE0003818359

quote:

NielsjeB schreef op 18 april 2018 21:24:

Effect of filgotinib, a selective JAK 1 inhibitor, with and without methotrexate in patients with rheumatoid arthritis: patient-reported outcomes

Received: 28 November 2017 Accepted: 8 February 2018
Published online: 23 March 2018

arthritis-research.biomedcentral.com/...
twitter.com/DrJuanOvalles/status/9866...

quote:

Beurskingpin schreef op 19 april 2018 09:34:

[...]

Finch2?

quote:

Lingus schreef op 19 april 2018 19:23:

...
The conclusion section of the FDA's document (p. 186) begins: "Overall, the additional data provided in the resubmission did not substantially alter the efficacy and safety data in the original submission. Thus, questions remain regarding the benefit/risk assessment of baricitinib for RA patients."
seekingalpha.com/news/3346815-eli-lil...

quote:

maxen schreef op 19 april 2018 20:39:

[...]
Even de conclusie helemaal:

Resubmission Conclusions
Overall, the additional data provided in the resubmission did not substantially alter the efficacy
and safety data in the original submission. Thus, questions remain regarding the benefit/risk
assessment of baricitinib for RA patients.
Both the 2 and 4 mg doses of baricitinib demonstrated efficacy compared to placebo in RA
patients. Given the safety issues identified with baricitinib, whether there is additional benefit of
the 4 mg dose over the 2 mg dose is an issue we would like you to discuss at the AC meeting.
Baricitinib has several safety signals consistent with a potent immunosuppressive. Thrombosis
is a notable safety issue and we ask for you to discuss this safety issue and how that impacts the
benefit/risk profile of baricitinib. Since most of the safety data are with the 4 mg dose of
baricitinib and there are limited placebo control data, interpretation of the safety data is
challenging, particularly when events continue to accrue in patients treated with open-label
baricitinib. This raises the question of whether the 2 mg dose has a favorable benefit/risk profile;
however, an important issue is whether there is sufficient safety data to inform the benefit/risk
assessment of the baricitinib 2 mg dose. We ask for your input on all of these issues and look
forward to the discussion.

De toegevoegde data van de resubmission voegen nauwelijks wat toe aan de effectiviteits- en veiligheidsdata van de eerste submission.
Voor 2mg eigenlijk te weinig safety data.
Het blijft daarom onduidelijk of 2mg beter (want:minder bijwerkingen) is dan 4mg (wellicht wat effectiever).
Te weinig placebo data. "Events" (lees: trombose-achtige problemen) blijven maar voorkomen bij patienten die via open-label baricitinib voorgeschreven krijgen.

Kortom: ziet er niet heel goed uit.

quote:

Opop schreef op 19 april 2018 20:16:

FDA staff raises safety concerns over Lilly/Incyte arthritis drug

This could be a positive for competitors such as AbbVie and Gilead and Galapagos that have their own oral JAK inhibitors in late-stage development," wrote Credit Suisse analysts.

kfgo.com/news/articles/2018/apr/19/fd...

quote:

avantiavanti schreef op 23 april 2018 14:43:

[...]

Voor wie tijd/interesse heeft om de cast te volgen vanmiddag:

April 23, 2018, Meeting of the Arthritis Advisory Committee (AAC) –

Webcast Information
The meeting webcast can be accessed at the following web address:

collaboration.fda.gov/aac042318/
Note: At the access page, please sign in as a guest. No password is required.

quote:

MrBerth schreef op 23 april 2018 17:16:

[...]

Hoe laat? (ik zie dat het nu al bezig is, is er een agenda?)

quote:

avantiavanti schreef op 23 april 2018 17:22:

[...]

Hij is bezig sedert een uur. Ik kan cast niet volgen want op reis, maar kijk wel met 1 oog op twitter updates baricitinib. Bijvoorbeeld:

#FDA’s Robert Abugov tells #AAC that both doses of $LLY’s baricitinib are clinically effective, but the difference between the doses is “likely pretty small.” He says the evidence doesn’t support the company’s proposed dosing strategy.

quote:

MrBerth schreef op 23 april 2018 17:24:

Ik zit nu in de cast, maar ben geen expert of kenner van de materie.

quote:

MrBerth schreef op 23 april 2018 17:35:

2mg treatment lijkt niet voldoende te zijn, dus als de 4mg niet wordt toegestaan blijft er weinig over lijkt me voor baricitinib...