Alkermes generic for blockbuster schizophrenia med Abilify bags FDA nod
- The FDA on Monday approved Alkermes' Aristada (aripiprazole lauroxil), a generic version of Otsuka's blockbuster Abilify.
- Aristada is administered every four to six weeks via an injection in the arm or buttocks.
- Approval is based on the strength of data from a 12-week, phase 3 trial showing the Aristada successfully reduced the signs and symptoms of schizophrenia.
When Abilify, which was co-launched by Bristol-Myers Squibb (BMS) and Otsuka in early 2003, was approved, it was seen as a new, potentially better treatment for schizophrenia with a lower rate of associated weight gain. It was approved in the E.U. in 2004, and went on to become a blockbuster antipsychotic in the global market with sales consistently above the $6 billion mark at its height.
There were various patents covering Abilify, which meant that generics could not be introduced into the market until earlier this year, when Teva introduced the first generic in April.
A couple of notes: Aristada is not approved to treat patients with dementia-related psychosis. The most common adverse reactions in a clinical trial were insomnia, headaches and akathisia, a form of inner restlessness. In addition, the approval for Aristada covers schizophrenia only. Abilify has indications beyond schizophrenia, including major depressive disorder and bipolar-mania disorder.
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