MHRA grants Lumevoq® (lenadogene nolparvovec) ophthalmic gene therapy ‘Promising Innovative Medicine Designation’ for Leber Hereditary Optic Neuropathy (LHON)

LHON is a rare genetic disease that results in severe and irreversible vision loss that mainly affects adolescents and young adults. Lumevoq is is intended for the treatment of vision loss due to LHON caused by a confirmed G11778A mutation in the ND4 mitochondrial gene.

SPS commentary:

Lumevoq® is not yet licensed in the EU or in the UK. Its Marketing Authorisation Application is currently under review by the European Medicines Agency, with a decision expected in first half of 2022.

Biospace Inc.