Aristada gets go-ahead from FDA

On Monday, the Food and Drug Administration gave permission to Alkermes PLC’s schizophrenia treatment. The drug Aristada will be available in monthly and six-week dosing options. The company wants to introduce the drug immediately.

Aristada is in injectable form of Abilify developed by Japanese drugmaker Otsuka Pharmaceuticals and sold by Bristol-Myers Squibb in the US. It is available as once-a-day oral medication.

Schizophrenia is a serious, disabling brain disorder that affects around 1% of the US population. Patient suffering from it often suffer from psychotic experiences, including hallucinations and delusions. Aristada is not meant to treat patients with dementia-related psychosis.

As per analysts, US sales for long-acting injectable versions for the treatment of schizophrenia will more than double to $3 billion by 2020. There are many other injectable versions as well like Eli Lilly's Zyprexa Relprevv and Otsuka's once-monthly Abilify Maintena.

As per Thomson Reuters Cortellis, Aristada is expected to have peak sales of around $550 million by 2020. The approval of the drug comes with a boxed warning that the drug is not approved for with dementia-related psychosis.

The warning also says that elderly with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. As said above, the company wants to start the sales of the drug as soon as possible and has been working on that front.