With Tuesday's FDA nod for Alkermes' Lybalvi, adults with schizophrenia and bipolar I disorder will soon have a treatment option that will help them maintain a healthy weight.
Following the approval, Alkermes will bring to market a drug that it hopes will be an improvement on Eli Lilly’s Zyprexa, one of the most effective treatments for schizophrenia but one that's also shown to lead to significant weight gain.
Lybalvi is a combination of olanzapine, the active ingredient of Zyprexa, and samidorphan, an opioid antagonist designed to counter the metabolic side effects of olanzapine. For the launch, Alkermes plans to rely on its market presence with another antipsychotic drug, Aristada, to “provide an important foundation for the commercialization of Lybalvi," CEO Richard Pops said in a statement.
Despite the FDA's approval, concerns remain about how the treatment will affect patients taking morphine or oxycodone. These include reduced painkilling, withdrawal symptoms and opioid overdose. Alkermes will address those concerns with a warning label.
The company hopes to bring Lybalvi to the market in the fourth quarter of this year.
“People living with schizophrenia or bipolar I disorder must evaluate both efficacy and tolerability when making treatment decisions,” Paul Gionfriddo, CEO of Mental Health America, said in a statement Tuesday. “We are grateful that companies like Alkermes are driven to continue developing new treatment options in psychiatry that seek to address unmet needs of our community and we applaud the FDA for considering the experiences of individuals living with these conditions.”
When the FDA’s Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee met last October to discuss Lybalvi, they voted 15-1, with one abstention, that the drug was effective and prevented weight gain. But by an 11-6 vote, experts were divided on whether a label warning would sufficiently capture the risks.
The approval comes after the FDA sent a complete response letter (CRL) to the drug company in November of last year over concerns at a manufacturing site in the production of Lybalvi.