Alkermes wins FDA nod for combo med with antipsychotic olanzapine — this time without the weight gain red flags
Alkermes has had a rough go in the past few years, making the decision to slice away a healthy portion of its R&D workforce last year after a major setback in depression. The drugmaker placed a lot of hope in antipsychotic drug ALKS 3831 to turn things around, and after a winning adcomm late last year that bet is finally paying off.
The FDA on Tuesday approved Alkermes’ Lybalvi (olanzapine and samidorphan) to treat schizophrenia and bipolar 1 disorder, the company said in a release.
The drug was approved as a maintenance monotherapy, or for the acute treatment of manic or mixed episodes as a monotherapy or adjunct to lithium or valproate, Alkermes said. Lybalvi is a combination of novel chemical samidorphan and antipsychotic olanzapine, an aging antipsychotic considered one of the field’s most effective despite previous red flags over patients’ weight gain.
But with the new formulation, Alkermes thinks it has cracked the code on those prior olanzapine issues. The agency based its review on expansive data from Alkermes’ ENLIGHTEN program, which included 27 clinical studies, including 18 studies testing Lybalvi and nine studying samidorphan alone, the company said. Among those, ENLIGHTEN-2 churned out data showing schizophrenia patients on Lybalvi posted significantly less weight gain than patients taking olanzapine alone.
Alkermes $ALKS shares were trading up about 6% before the bell Tuesday.
Lybalvi will come with a black box warning for increased risk of mortality in elderly patients with dementia-related psychosis, according to its label. That warning is tied to reported cases of cerebrovascular side effects in clinical trials, including stroke and transient ischemic attack. The drug will come with contraindications for patients taking opioids or who are undergoing acute opioid withdrawal.
The drugmaker expects Lybalvi to hit the market in the October/November timeframe and plans to lean on its existing commercial infrastructure from marketed antipsychotic Aristada to grease the wheels for the new drug’s successful launch, according to a release. The team will add 50 sales reps to that Aristada “core,” CCO Todd Nichols said on a Tuesday morning call with investors, as it works to ramp up commercial manufacturing and finalize its promotional claims prior to a full rollout at launch.
Alkermes didn’t release the list price, saying it was waiting on payer negotiations prior to launch.
Antipsychotics is an unusual market, with most first-line scripts dominated by generics although a proportion of patients eventually cycle through those early drugs. That means the potential market for Lybalvi will likely take a while to develop, with Alkermes predicting around $10 million in sales by the end of the year.
“We have established a profile that there will be a pathway to access at launch, but it will develop over time,” Nichols said. “They’re most likely going to have to step through one or two generics before access, and we’re prepared for that.”
Lybalvi, formerly dubbed ALKS 3831, faced an FDA advisory committee in October during which the question of a potential REMS was proposed for the drug. The committee voted 11-6 that potential labeling was enough to mitigate risk, a big draw for Alkermes in the heavily regulated antipsychotic space.