SMA Newsroom

Jul 16, 2021

Apitegromab granted Fast Track Designation in the US for the treatment of SMA

Scholar Rock has received Fast Track Designation in the US from the FDA for apitegromab for the treatment of SMA.

Apitegromab (also known as SRK-015) is a muscle-directed therapy that aims to reverse or restrict the muscle atrophy and weakness experienced by people living with SMA.

Fast Track status is granted to drugs that show considerable potential for being able to treat life-threatening conditions that have limited therapeutic options. The new designation will help to speed up the development and review processes of the promising drug and adds to its orphan drug status.

Similar to the Fast Track Designation, The European Medicines Agency (EMA) has previously granted apitegromab Priority Medicines (PRIME) designation, recognising unmet medical needs of people living with SMA.