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.
Alkermes is now clear to introduce Lybalvi into a crowded market for neuropsychiatric drugs in which the first-line of prescribed treatments are generic medications. Speaking on a conference call, Alkermes CEO Richard Pops noted that the average schizophrenia or bipolar disorder patient switches therapies five times over a lifetime in the search of the medication offering the best balance of efficacy and tolerable side effects. The company believes Lybalvi can capture market share as patients make these switches.
Lybalvi, a once-daily pill, combines the antipsychotic medication olanzapine with samidorphan, a new chemical entity. Olanzapine is an old drug that has a long track record as an effective treatment for schizophrenia and bipolar disorder. The reasons why olanzapine leads to weight gain are not well understood, but this side effect can lead patients to discontinue treatment or seek alternatives. Samidorphan is intended to lessen the weight gain side effect by binding to opioid receptors, an approach that has been shown to regulate weight and metabolism.
For patients prescribed opioid medications, Lybalvi’s effects on opioid receptors may lead to withdrawal symptoms, the drug’s label cautions. Another risk is that patients who experience diminished effects of their prescribed opioid medication may try to compensate by taking more of the opioid, leading to potentially fatal complications.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Regulatory approval of Lybalvi does not require a risk evaluation and mitigation strategy, a formal plan that warns physicians and patients about a drug’s risks. Such a strategy was discussed during the October advisory committee meeting. The label does include a boxed warning cautioning that elderly patients treated with antipsychotic drugs face a higher risk of death, and that FDA approval of Lybalvi does not include treating patients with dementia-related psychosis.
The Alkermes drug may be used by itself or as an adjunct to lithium or valproate, two other medications used to treat bipolar disorder. Todd Nichols, the company’s senior vice president and chief commercial officer, said that between 2 million and 3 million patients in the U.S. suffer from schizophrenia, and a similar number of patients are affected by bipolar disorder. For those patients, generic drugs represent 90% of the prescribed medications and they will continue to be the first treatment choice for patients. But Nichols added that of the 70,000 patients who switch therapies each month, about 15,000 switch to a branded product. Alkermes aims to capture switching patients with four different dosage options.
“If a patient is not getting the benefits of a product they need, the first thing that they do is they change the dose, which is an advantage for Lybalvi because we have multiple dosing options,” Nichols said. “The second thing that they would do is they would switch the product. That gives us the chance to compete in a very large switch market.”
Alkermes has not yet finalized the claims it will make about the weight gain mitigating effects of Lybalvi, nor has the company disclosed a price. Nichols said the company is still negotiating with health insurers, so the drug claims and the price will be released in coming months closer to the product’s expected launch in the fourth quarter of this year.
The FDA’s rejection of Lybalvi last November was due to problems with the tablet-coating process at the company’s Wilmington, Ohio manufacturing plant. The Covid-19 pandemic has affected the FDA’s ability to conduct in-person inspections of facilities, but Pops said the agency’s concerns could be addressed remotely.
“We generated as much data as possible to facilitate FDA’s remote records review with the goal of avoiding the need for an on-site inspection or another review cycle, and this was a successful strategy,” he said.
Image: Aleksei Morozov, Getty Images
