Lundbeck, Otsuka seek Abilify Maintena nod in bipolar disorder

Lundbeck and Otsuka have announced that the FDA will review their Abilify Maintena in bipolar I disorder.

Riding strong sales momentum with Abilify Maintena, partners Otsuka and Lundbeck are setting out for a label expansion in the U.S. for their long-acting injectable antipsychotic. If approved, the indication would offer a new sales route as the companies seek to navigate significant generic challenges.

The FDA has accepted the partners’ application in bipolar I disorder and expects to issue a decision by July 28, 2017, the companies said in a statement.

Otsuka and Lundbeck won U.S. approval for the once-monthly schizophrenia treatment back in 2013. If the FDA grants the expansion, the partners will have a new avenue to grow sales in a lucrative field where oral atypical antipsychotics have made their mark in the past.

For Otsuka, the application comes following a year in which generics have taken a toll on the stalwart Abilify. Last summer, the company lost a struggle to prevent generics to the blockbuster. It’s also facing a newer challenge from Alkermes, which has introduced an Abilify Maintena copycat dubbed Aristada.

Under their alliance, Lundbeck has comarketing rights to Abilify Maintena in North and Latin America, Europe, Australia and some other countries. In its 2015 results, the Danish company said the drug posted sales 220% higher than the previous year to 669 million Danish kroner ($95.5 million). All regions contributed to that expansion, with Europe leading the charge.

That trend continued in the first half of this year, with Lundbeck reporting that the injectable nearly doubled sales to 534 million kroner ($76 million). Analysts have projected peak sales of $500 million to $1 billion for the treatment.

But before returning to profitability in the first quarter of 2016, Lundbeck last year had to swing the axe on 1,000 jobs in a corporate refocus around five key meds, Abilify Maintena being one in that group.

Responding to some of the generic erosion, Otsuka and Lundbeck last July won an FDA green light last July for Rexulti to treat schizophrenia and as an add-on for major depression. That drug grew to 309 million kroner in the first half following its August 2015 launch, Lundbeck said.