Alkermes plc — Lybalvi FDA Review (NDA213378, ORIG 1, 2021)
Alkermes plc · 2021 · FDA Review (openFDA) · company profile →
Report summary
The FDA review of Alkermes' Lybalvi (olanzapine/samidorphan) for schizophrenia and bipolar I disorder highlighted its efficacy in reducing PANSS scores and significantly mitigating olanzapine-associated weight gain. However, the application received a Complete Response due to unresolved manufacturing issues. The review also addressed opioid-related safety concerns due to samidorphan's opioid antagonist action, including precipitated withdrawal and inadequate analgesia. Studies demonstrated Lybalvi's antipsychotic efficacy and less weight gain compared to olanzapine alone, with generally acceptable safety profiles. Pharmacokinetic studies confirmed bioequivalence and characterized drug interactions. Preclinical data supported samidorphan's role in mitigating metabolic side effects. The FDA required pediatric studies and postmarketing recommendations.
Key findings — cited to the page
| Advisory Committee vote: labeling sufficient to mitigate risks related to opioid antagonist action of samidorphan | 0 Abstain votes | · p.35 |
| Safety Population for ALKS 3831 Development | 2004 N | · p.89 |
| incident of precipitated opioid withdrawal in samidorphan-only trial | 1 | · p.34 |
| Advisory Committee vote: adequate evidence samidorphan mitigates olanzapine-associated weight gain | 16 Yes votes | · p.35 |
| Advisory Committee vote: adequate evidence samidorphan mitigates olanzapine-associated weight gain | 1 No votes | · p.35 |
| Advisory Committee vote: adequate evidence samidorphan mitigates olanzapine-associated weight gain | 0 Abstain votes | · p.35 |
| Advisory Committee vote: Applicant adequately characterized safety profile of ALKS 3831 | 13 Yes votes | · p.35 |
| Advisory Committee vote: Applicant adequately characterized safety profile of ALKS 3831 | 3 No votes | · p.35 |
| Advisory Committee vote: Applicant adequately characterized safety profile of ALKS 3831 | 1 Abstain votes | · p.35 |
| Advisory Committee vote: labeling sufficient to mitigate risks related to opioid antagonist action of samidorphan | 11 Yes votes | · p.35 |
| Advisory Committee vote: labeling sufficient to mitigate risks related to opioid antagonist action of samidorphan | 6 No votes | · p.35 |
| fetal loss and skeletal abnormalities at MRHD multiple | 5.5 times | · p.38 |
Source: Alkermes plc ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Psychiatry library →