News and Reports | April 23, 2026
WASHINGTON, D.C. — Regeneron is the latest drugmaker to reach a most-favored-nation (MFN) pricing agreement with the Trump administration, part of a broader set of voluntary deals aimed at bringing U.S. drug prices in line with those in other high-income countries. The company was the last of the 17 corporations that received letters in July 2025.
The White House announced the MFN agreement alongside the FDA’s expedited approval of Otarmeni, a gene therapy developed by Regeneron to treat a rare form of genetic deafness affecting approximately 50 Americans born each year. The approval was granted through the agency’s National Priority Voucher program. FDA guidance for the voucher program includes “affordability” — such as aligning U.S. drug prices with MFN benchmarks — as a qualifying criterion for accelerated review, effectively linking pricing concessions to regulatory benefits.
Facing pressure from the administration’s proposed tariff policy, Regeneron has agreed to reduce Medicaid prices for certain current and future medications and to offer its cholesterol drug Praluent through TrumpRx. However, the privately negotiated short-term agreements remain voluntary and opaque, with limited public detail on how prices are set or whether savings will reach most patients.
“Today’s approval of Otarmeni is a landmark moment, and we are thrilled for the families who will be able to access this therapy for free,” said Merith Basey, CEO of Patients For Affordable Drugs. “But one company’s goodwill is not a sustainable solution to the prescription drug affordability crisis that Americans are facing. Voluntary, company-by-company agreements do not change the fundamental dynamic that gives Big Pharma the power to set and raise prices at will. Lasting relief for patients requires systemic reforms that lower drug prices for good.”
While Regeneron has committed to providing the treatment at “no cost” to Americans with the disease — a notable step in a market where similar therapies are often priced in the millions — it remains unclear what safeguards are in place to ensure long-term affordability. This is not the first time this pattern has played out. After Eli Lilly signed its MFN deal with the administration and committed to including Zepbound and Orforglipron on TrumpRx, Orforglipron then received a National Priority Voucher and was approved months later. The same pattern extends to Novo Nordisk with Wegovy, Boehringer Ingelheim with Zongertinib, Johnson & Johnson with Bedaquiline, among others.
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Patients For Affordable Drugs is the only national patient advocacy organization focused exclusively on policies that lower prescription drug prices. We empower and mobilize patients by amplifying their experiences with high drug prices to hold those in power to account and fight to shape and achieve system-changing policies that make prescription drugs affordable for all people in the United States. P4AD does not accept funding from organizations that profit from the development and distribution of drugs. To learn more, visit PatientsForAffordableDrugs.org