15 Sep 2020
Posted in Pharma
October FDA Advisory Committee meeting on Alkermes’ ALKS-3831 has mixed expectations on weight gain data discussion
Alkermes’ schizophrenia/bipolar disorder candidate ALKS–3831 weight gain data will be at the forefront of a 9 October FDA Advisory Committee (AdCom) meeting, but how the panel members will evaluate it is up for debate, as reported by William Newton, Pharma Writer for the Investigative News team at GlobalData, a leading data and analytics company.
Newton comments: “The AdCom will question whether ALKS–3831, which is a combination of an opioid antagonist and the generic drug olanzapine, provides a clinically valuable weight gain reduction versus olanzapine.
“There is also the potential for concern over the lack of significant differentiation in the lipid and glycemic parameters between ALKS–3831 and olanzapine, as well as the study’s high drop-out rate and number of missing weight assessments. In turn, these objections could influence the AdCom’s recommendations and the subsequent FDA regulatory decision.”
Newton adds: “That said, the primary weight change endpoints, which were met in a Phase III study, were designed based on preliminary discussions between Alkermes and the FDA. The understanding was ALKS–3831 would be approved if it achieved these endpoints without any added toxicity.
“If ALKS–3831 is approved, many olanzapine prescribers would attempt to switch their patients to ALKS–3831 when possible, but there may be payer barriers like stringent prior authorization and copayment requirements.”
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