Amarin’s MAA for Huntington’s drug accepted for review by EMEA

Amarin, a biopharmaceutical company, has announced that the European Medicines Agency has accepted for review the company’s marketing authorization application for AMR101 in patients with Huntington’s disease.

The application is based on clinical data which includes results from the company’s multi-centre, double-blind, placebo-controlled Phase III study of AMR101 in 316 patients with Huntington’s disease conducted in the US and Canada.

The filing also included data from a magnetic resonance imaging study investigating the comparative effects of AMR101 and placebo on the cerebral pathology of patients with Huntington’s disease.

AMR101 has been designated as an orphan medicinal product in the EU for the treatment of Huntington’s disease, which, if approved, entitles the drug to 10 years of market exclusivity for the approved indication. Amarin has also secured patents for the use of AMR101 to treat Huntington’s disease, with expiry dates ranging from 2020 to 2023.

Thomas Lynch, CEO of Amarin, said: We are pleased to have our European Medicines Agency (EMEA) filing for AMR101 in Huntington’s disease accepted for review as it is a disorder of great unmet medical need. Given the excellent safety and tolerability profile of AMR101, and the significant impact it demonstrated in a Phase III trial on slowing the disease progression over 12 months, it could offer patients a much needed advance in treatment.