What they're not telling you: Authored by Zachary Stieber via The Epoch Times (emphasis ours), Federal regulators on Thursday approved the first gene therapy to restore hearing, just two months after the therapy’s maker formally requested a license. Marty Makary, the Food and Drug Administration's commissioner, in an undated file photograph. Madalina Vasiliu/The Epoch Times The Food and Drug Administration approved the Regeneron therapy, Otarmeni, for children and adults with severe or profound hearing loss associated with OTOF gene variants.
# THE TAKE: FDA's Deaf Spot on Gene Therapy Economics The FDA's deafness gene therapy approval is regulatory theater masking a brutally simple truth: this "breakthrough" will treat maybe thousands while enriching Regeneron and leaving the actual deaf infrastructure to rot. Let's be precise. This therapy costs ~$250K per ear. Insurance covers some. Most don't. The deaf community didn't ask for genetic "fixes"—they asked for accessible housing, real-time captioning, and workplace accommodation. Those cost less. They're just less profitable. Notice what wasn't approved: mandates for accessible design, enforcement of ADA compliance, investment in ASL education. The FDA greenlit a drug. Capital celebrated innovation while sidestepping systemic change. This is how corporate power operates. It offers individual medical solutions to collective political problems, then claims neutrality. Deaf communities gain access to the hearing world's standards—not equality within their own. The story isn't about hearing restoration. It's about which problems get solved when solving them serves shareholders.
What the Documents Show
The approval came 61 days after Regeneron filed for a biologics license, under a new effort known as the Commissioner’s National Priority Voucher Program that emphasizes quickly reviewing applications for products that address unmet needs. “ Today’s approval is a significant milestone in the treatment of genetic hearing loss ,” Dr. Marty Makary, the FDA’s commissioner, said in a statement. “Through the national priority voucher pilot program, the agency is accelerating therapies for rare diseases with unmet medical needs while proving we can successfully review even the most complex submissions—such as novel dual vector gene therapies and combination products requiring coordination across multiple offices and centers—in significantly shortened timeframes.” Genetic mutations account for about half of cases of inherited hearing loss. Variants in the OTOF gene account for 2 to 8 percent of those cases.
Follow the Money
To treat deafness, Otarmeni is administered to each ear using a syringe and catheter provided in the accompanying kit. Regulators approved Regeneron’s therapy after reviewing data from a clinical trial involving 24 patients aged 10 months to 16 years. Of the 20 patients included in the efficacy analysis, 80 percent experienced improvement in hearing after receiving Otarmeni. Common side effects of the drug included ear infection, nausea, and dizziness. Eliot Shearer, an otolaryngologist at Boston Children’s Hospital and an investigator in the trial, said in a statement released by Regeneron that the one-time therapy provides “remarkable hearing improvements.” “I’ve witnessed firsthand my trial participant responding to their mother’s voice, dancing to music and interacting with the world, and these moments are now possible for more children born with this specific form of hearing loss,” he said. Marty Makary, the Food and Drug Administration's commissioner, in an undated file photograph.
What Else We Know
Madalina Vasiliu/The Epoch Times Regeneron said it will provide the therapy free of charge to patients in the United States as part of a deal struck with President Donald Trump and announced on Thursday. Yancopoulos, president and chief scientific officer of Regeneron, said in a statement that Otarmeni was an “unprecedented breakthrough” in gene therapy. “Otarmeni is a huge scientific leap and is representative of Regeneron’s approaches to continually push the boundaries of science to benefit humanity,” he said. “This unprecedented breakthrough in gene therapy has already proven to be life-changing for many of the children in our clinical trial and their families. We are honored to be in the position to be the first company to ever offer such a gene therapy advance for free to those in the U.S. and serves to highlight our belief that the biopharmaceutical industry can be a genuine force for good in the world.” Make sure to read our "How To [Read/Tip Off] Zero Hedge Without Attracting The Interest Of [Human Resources/The Treasury/Black Helicopters]" Guide It would be very wise of you to study our privacy policy and our (non)policy on conflicts / full disclosure .
Primary Sources
- Source: ZeroHedge
- Category: Money & Markets
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