Regeneron Strikes Drug Pricing Deal with Trump, Offers Free Groundbreaking Gene Therapy for Deafness

Deep News
04/24

The White House announced on Thursday that Regeneron Pharmaceuticals has entered into a cooperative agreement with U.S. President Donald Trump to lower drug prices for a segment of the American population. Earlier that same Thursday, the company's groundbreaking new therapy received regulatory approval. Following this approval, Regeneron committed to providing the world's first gene therapy for hereditary deafness free of charge to eligible U.S. patients. Regeneron is the latest major pharmaceutical company to reach a pricing agreement with the Trump administration. The administration's framework for these agreements is based on a Most Favored Nation policy, aiming to align U.S. prescription drug prices with the lowest levels found in other developed nations. In exchange for the agreement, the U.S. will grant these pharmaceutical companies a three-year tariff exemption. This includes tariffs of up to 100% that the President had previously planned to impose on certain drugs. A deputy administrator from the Centers for Medicare & Medicaid Services stated at a White House event that the administration has now finalized 17 such agreements and is in discussions with other biotech and pharmaceutical firms for further collaborations. The agreement with Regeneron was reached just hours after the U.S. Food and Drug Administration (FDA) approved the company's gene therapy, Otamemi. This treatment can restore hearing in a small number of children with hearing loss. The therapy received accelerated approval through the FDA's Priority Review Voucher program. The therapy targets an extremely rare genetic condition where a gene mutation prevents the production of a protein essential for hearing, leading to deafness. For this specific patient population, who have long relied on cochlear implants, the approval represents a significant medical breakthrough. Analysts from Piper Sandler estimated in a March research report that the peak annual sales for this gene therapy could reach $130 million.

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