Dublin drug firm Alkermes gets FDA go-ahead for schizophrenia treatment

Dublin-headquartered pharmaceutical firm, Alkermes has gained US regulatory approval to start marketing its schizophrenia treatment, Aristada.

The US company, which changed its tax and corporate base to Dublin four years ago following its €1bn acquisition of the Athlone-based drug delivery business of former Irish biopharmaceutical firm, Elan, announced FDA approval on Monday night.

Aristada is a ‘generic’ longer-acting injectable version of existing blockbuster schizophrenia pill Abilify, which is made by Japanese drug firm, Otsuka Pharmaceuticals and sold in the US by Bristol-Myers Squibb.

Alkermes’ version is set to be launched immediately

“Aristada is a new treatment option designed to offer flexibility to meet the real-world needs of patients suffering from schizophrenia and the healthcare professionals providing their care,” said Elliot Ehrich, Alkermes’ chief medical officer.

“Building on nearly two decades of experience developing innovative medicines for chronic and serious CNS diseases, we are dedicated to helping to improve the lives of patients as well as meeting the needs within the treatment ecosystem of caregivers, physicians, payers and society.”

“Schizophrenia is a serious and debilitating disease where, despite the existence of many medicines, there remains significant unmet medical need and suffering,” said David Henderson, associate professor of psychiatry at Massachusetts General Hospital.

“New treatment options are needed to help patients and their families better manage this illness,”