avantiavanti schreef op 20 april 2018 08:50:
GILD/GLPG: Despite FDA's Bari Criticisms, No Change To Our View On Filgotinib
April 19, 2018
RBC Capital MarketsBrian Abrahams (Analyst) (212) 858-7066;
brian.abrahams@rbc.com FDA briefing documents were posted this morning for the upcoming baricitinib AdComm and show significant debate within the agency on the benefit/risk of that drug (see our note here) - recall GILD/GLPG's filgotinib is in the same general Jak inhibitor class and is also being tested in RA (as well as other diseases). Despite this scrutiny, we do not see major read-throughs either way for filgotinib-- on one hand, reviewers made a point that thrombosis is likely not a class effect, suggesting they will consider each drug's profile individually, though on the other hand, the documents do highlight the high safety bar in RA. Approval of bari at only its lower 2mg dose would reduce its RA competitiveness and could improve filgotinib's commercial positioning (though filg could get the same treatment by Agency); also, we note benefit/risk of filg would likely be less scrutinized in IBD (which accounts for ~2/3 of our out-year prob-adjusted $3.2B sales estimate) anyway. We remain relatively positive on filgotinib's potential though we believe more optimism for the agent is already reflected in GLPG shares vs. GILD shares.
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.
On the other hand, given availability of treatment for RA including other JAK inhibitors, the FDA clearly does not consider RA an area of high unmet need, and any imbalances in this indication may be highly scrutinized. Even though the number of thromboembolic events in baricitinib clinical trials were low and did not reach the threshold of statistical significance, one of the reviewers remained highly concerned over the numerically higher number of thrombotic events in the baricitinib arm, which they comment is not seen in other approved RA therapies. We believe this reveals a high safety bar for approval in RA, and believe that any potential safety imbalances that could potentially emerge in filgotinib clinical trials would be given the same high level of scrutiny. We also note that, as we pointed out in our initiation reports on GLPG and GILD , this division tends to steer labels towards lower doses in RA.