India, May 22 -- Regeneron Pharmaceuticals Inc. (REGN), a biotechnology company, on Friday reported the acceptance of a Market Authorization Application (MAA) review by the European Medicines Agency (EMA) for Otarmeni, a gene therapy developed to treat OTOF-associated hearing loss.
Biallelic OTOF variant-associated hearing loss is caused by mutations in the OTOF gene, leading to the absence of a functioning otorfelin protein. The protein is essential in communications between the auditory nerve and sensory cells of the inner year. Treated by the use of hearing devices that can amplify sound but fails to restore hearing across the spectrum, OTOF-associated hearing loss was believed to be permanent.
Otarmeni (lunsotogene parvec) is an in vi...