After manufacturing setback, FDA OKs new schizophrenia drug

June 1, 2021

Alkermes announced this week that the FDA has approved its new treatment for schizophrenia and bipolar 1 disorder. 

The therapy, called Lybalvi, is a once-daily oral treatment comprised of olanzapine, an approved antipsychotic, and a new chemical entity, samidorphan. 

Although the medication includes an established antipsychotic, it helps stave off a difficult side effect associated with the current treatments — significant weight gain. According to the company, late-stage trials showed that Lybalvi was shown to be as effective as current therapies with less weight gain associated with the drug. 

Yet, the FDA rejected the drug’s approval in November because of tablet coating concerns at its manufacturing facility.

Now that the company has been given the go-ahead, it plans to launch the product by the fourth quarter.