Met dank aan AvantiAvanti voor het plaatsen van de analisten reports (goed werk!), wat geselecteerde punten:
Nomura:
Further Delays Bode Well for PFE’s Xeljanz, ABBV’s Upadacitinib, and
GLPG/GILD’s Filgotinib--the Safer JAK Inhibitor. Filgotinib in cross-trial
comparisons has the lowest rate of DVT and PE (Fig. 1) and a positive
reduction in platelets. We maintain that filgotinib has a safety advantage
over upadacitinib (ABBV).
Cross Current research
In a nut shell: Lilly pissed off the FDA reviewers. Lilly really, we mean really, pissed them off.
One legitimate concern is the thrombotic events. That could potentially be related to JAK
inhibition, as the mechanism does affect platelets.
RBC
On one hand, reviewers made the specific point that VTEs (thrombolic events) do not appear to be an overall class effect of JAK1/2 inhibitors. The documents specifically discussed differences in rates of adverse events between bari and tofacitinib, an approved JAK inhibitor for RA, speculating that differences in JAK selectivity could account for the imbalances seen. Filgotinib has not shown as significant imbalances in VTEs and has a more JAK1 selective profile vs. bari or tofa, and we believe the VTE question will not influence the FDA's views on filgotinib, and filgotinib will be evaluated solely based on the safety signals observed in its own clinical studies.