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US FDA Clears First-Ever Gene Therapy For Children Born Deaf Due To Genetic Mutation
No More Silence: US FDA Clears First-Ever Gene Therapy For Children Born Deaf Due To Genetic Mutation
For a child born completely deaf, the world has largely been one of silence—broken only by the mechanical cochlear implant or a hearing aid. That may be about to change. On April 23, the US Food and Drug Administration granted accelerated approval to Otarmeni, developed by American drugmaker Regeneron Pharmaceuticals.
Otarmeni (lunsotogene parvec-cwha) is the first-ever dual adeno-associated virus (AAV) vector-based gene therapy. Motivated by positive results, Indian doctors told News18 they are also exploring collaborations to conduct similar studies in India and generate local clinical data.
“Otarmeni is indicated for the treatment of paediatric and adult patients with severe-to-profound and profound sensorineural hearing loss associated with molecularly confirmed biallelic variants in the OTOF gene," the agency said while adding, “Prior to today’s approval, no disease-modifying treatments existed for OTOF-related deafness. Otarmeni is for patients with preserved outer hair cell function and no prior cochlear implant in the same ear."
Following the US FDA’s announcement, Regeneron’s official press release also stated it is “the first gene therapy and second new molecular entity approved under the FDA Commissioner’s National Priority Voucher program"—a pilot initiative that compresses regulatory review to as little as one to two months.
Regeneron said it will make Otarmeni available free of cost to eligible patients in the United States.
The drug has received orphan drug, rare paediatric disease, fast track, and regenerative medicine advanced therapy designations from the FDA. The company said that the regulatory submissions are planned in additional markets. While India’s regulatory approval timeline has not been announced, it takes at least a year for a new drug to enter the Indian market.
According to the press release issued by the drugmaker, “though all structures within the ear are intact, variants in the OTOF gene cause a lack of a functional otoferlin protein, which is critical for communication between the sensory cells of the inner ear and the auditory nerve."
The machinery is all there, but the link between sound and the brain is broken.
“Historically, genetic OTOF-related hearing loss was considered permanent and managed with life-long use of devices" that “can amplify sound" but “do not currently restore the full spectrum of sound".
Otarmeni is an adeno-associated virus vector-based gene therapy. The drug delivers “a working copy of the OTOF gene through a modified, non-pathogenic virus that is delivered via an infusion into the cochlea under general anaesthesia—similar to the procedure used for cochlear implantation."
Otarmeni and the administration kit are a “one-time" biologic-device combination product.
The newly introduced gene is placed under the control of a proprietary Myo15 promoter, which, the company says, “is intended to restrict expression only to hair cells that normally express the otoferlin protein." It is designed as a one-time treatment.
The approval rests on results from the pivotal CHORD trial, in which 20 participants aged 10 months to 16 years received a single dose. The drugmaker describes Otarmeni as “the first FDA-approved example of a gene therapy to restore a neurosensory function to normal levels."
In the trial, 80% achieved the primary hearing endpoint at 24 weeks. Among those followed to 48 weeks, all prior responders maintained their response, and 42% achieved normal hearing that included whispers.
India carries a higher burden of congenital genetic hearing loss, partly due to the prevalence of consanguineous marriages in certain communities. Dr Atul Kumar Mittal, chairman of ENT at Fortis Hospital, Gurugram, says the development is directly relevant: “Congenital or genetic hearing loss is relatively common in India, especially in communities where consanguineous marriages are more frequent. Clinical trials in the United States involving about 20 patients have shown that nearly 60–70% experienced significant improvement in hearing, reducing or even eliminating the need for hearing aids or cochlear implants."
Experts believe that the drug is a major breakthrough that represents a big advancement in the management of genetic hearing loss. “Motivated by these results, we are exploring collaborations to conduct similar studies in India and generate local clinical data," Mittal said.
Dr Shama Shetty, consultant, ENT and head & neck surgery, SPARSH Hospital, Bengaluru, told News18 that while the approval of this gene therapy marks a great breakthrough in the management of genetic hearing loss, it is also significant to understand that this particular therapy is targeted at a very specific, ultra-rare genetic condition, and its applicability depends on the precise genetic diagnostics. “For the entire India, this development is promising but will require careful evaluation. While India does have a broad population with hearing impairment, only a small subset would have OTOF-related genetic hearing loss and qualify for such therapy."
The bigger problem, Shetty believes, will be access—availability of genetic testing, cost of therapy, infrastructure for advanced procedures, and regulatory approvals. “That said, this kind of innovation indicates the future direction of treatment—moving from management of symptoms to gene-level correction. In the upcoming years, as awareness, diagnostics, and infrastructure improve, such therapies could become more relevant and more accessible to Indian patients.
Source: News18
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