MedCity News Bouncing back from FDA rejection, Alkermes psychiatric drug wins approval Alkermes antipsychotic drug Lybalvi now has FDA approval. Though the field of neuropsychiatric drugs is crowded with generic medications, Alkermes believes Lybalvi, designed to mitigate the weight gain side effect common with mood disorder drugs, could have an advantage. Shares0
An Alkermes drug developed to offer antipsychotic effects while mitigating the weight gain associated with many depression medicines is now FDA approved as a new treatment options for patients. The regulatory decision announced Tuesday covers use of the Alkermes drug, Lybalvi, for two indications: schizophrenia and bipolar disorder I. It follows a contentious advisory committee meeting last October, during which several physicians expressed concern about the drug’s risks in patients who are already taking opioid medications, and an FDA rejection of the drug a month later due to a manufacturing problem.