April 23 (Reuters) – The U.S. Food and Drug Administration has approved Regeneron’s gene therapy for a rare genetic form of deafness, the company said on Thursday.
The company said the therapy will be available for free to patients in the United States.
The FDA’s nod paves the way for the first gene therapy for genetic hearing loss to enter the market.
The therapy branded as Otarmeni was approved under the Commissioner’s National Priority Voucher program for children born with hearing loss caused by gene mutations.
Regeneron gained ownership of the therapy when it acquired Decibel Therapeutics in 2023.
(Reporting by Sriparna Roy and Christy Santhosh in Bengaluru; Editing by Vijay Kishore)
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