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Alkermes Expects Gradual Ramp-Up For Lybalvi Launch

 
• By Joseph Haas

Alkermes’ combo pill of olanzapine and samidorphan gets US FDA approval; company predicts $10m first-year sales as schizophrenia/bipolar patients cycle through treatment options, including generics.

Brain scan
Alkermes hopes to slowly build market for new schizophrenia/bipolar therapy

Alkermes plc is preparing to launch Lybalvi (olanzapine/samidorphan) in the fourth quarter as a new treatment option for schizophrenia and bipolar I disorder with less weight gain than traditional olanzapine, and the company is guiding investors to expect a gradual ramp up as patients cycle through the various treatment options already available, including generics.

Lybalvi (previously ALKS 3831) cleared the US Food and Drug Administration 1 June for treatment of schizophrenia in adults as well as treatment of bipolar I disorder in adults, including acute treatment of manic or mixed episodes as monotherapy and as adjunct to lithium or valproate and as maintenance monotherapy treatment

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