Alkermes wins an FDA nod for its monthly schizophrenia drug

Alkermes ($ALKS) picked up FDA approval for a long-acting version of Otsuka's now-generic Abilify, planning to launch its injection as a treatment for schizophrenia.

Dubbed Aristada, Alkermes' drug is a monthly or every-6-weeks treatment that, once injected into the body, slowly transforms into aripiprazole, the active ingredient in Abilify. In a 12-week Phase III trial, Aristada led to a statistically significant improvement in schizophrenia symptoms compared with placebo.

Alkermes said it's ready to launch the new drug "immediately," hoping to carve out a spot in a crowded, competitive market. In April, the FDA approved four generics of Abilify, including one from Teva Pharmaceutical ($TEVA), imperiling the value of a drug that brought in $5.5 billion for Otsuka last year. The schizophrenia market is also flooded with generics of Risperdal, Seroquel and Zyprexa, plus a pair of newly approved branded drugs: Otsuka and Lundbeck's Rexulti, cleared in July, and Allergan ($AGN) and Gedeon Richter's long-delayed Vraylar, which won U.S. approval last month.

But Alkermes believes Aristada's lengthy half-life will help it stand out among so many treatments, including other monthly options. The drug is the only schizophrenia therapy approved for both every-four-weeks and every-6-weeks dosing, according to the company, and management believes there's enough unmet need to create demand.

Aristada is emblematic of Alkermes' guiding philosophy: taking established therapeutics and using new formulations or novel drug delivery to improve upon them. The company is at work on ALKS 3831, a Phase III take on the schizophrenia medicine olanzapine designed to duplicate that drug's effect without the attendant weight gain. Alkermes is also moving forward with ALKS 8700, an oral multiple sclerosis treatment designed to compete with Biogen's ($BIIB) blockbuster Tecfidera, and the Phase III depression treatment ALKS 5461.

- read the statement

Read more on