It’s been a busy few days for Regeneron Pharmaceuticals, which has inked a drug pricing agreement with the White House, while pledging to offer its newly approved rare hearing loss gene therapy, Otarmeni (lunsotogene parvec-cwha), for free to American patients.
By cutting a deal under US President Donald Trump’s Most Favored Nation (MFN) scheme, Regeneron will gain immunity from the 100% tariffs imposed by his administration on branded drug imports. In exchange, Regeneron will cut the price of its cholesterol-lowering therapy, Praluent (alirocumab) by 58% from $537 to $225, provided patients buy it through the administration’s direct-to-consumer (DTC) platform, TrumpRx.gov.
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Praluent is not the only portfolio drug Regeneron will slash prices on, as the New York-based pharma has pledged to offer all its new medicines at “MFN prices” moving forward.
This includes hearing loss gene therapy Otarmeni, which US regulators approved under the Commissioner’s National Priority Voucher (CNPV) scheme on 23 April, and will now be available to eligible US patients at no cost.
The therapy, which is suitable for patients with a rare form of genetic deafness linked to mutations in the OTOF gene, got the US regulatory go-ahead based on the outcomes of the Phase I/II CHORD study (NCT05788536). In the trial, 80% of patients with this condition, which impacts between 20 and 50 newborns per year in the US, experienced hearing improvements at 24 weeks.
Alongside its price-lowering pledges, Regeneron has vouched to pour $27bn into its US R&D and manufacturing capacity by 2029, which will see the New York-based pharma “more than double” its manufacturing capacity on home soil, as per a statement from the White House.
Regeneron is now the 17th big pharma company specifically called on by Trump to cut a deal with the White House, as the administration aims to lower drug prices to mirror peer nations.
Trump champions “America first” approach
As the US has traditionally grappled with sky-high drug prices, the Trump administration has been making several moves to turn this trend around and boost accessibility to drugs across America.
Alongside its MFN deals with giants like Johnson & Johnson (J&J), AbbVie and Pfizer, the administration has also strongly encouraged drugmakers to bolster their US manufacturing operations.
In a comment piece for Pharmaceutical Technology, GlobalData analysts noted that policy decisions are increasingly considering domestic manufacturing investments.
In a bid to slash weight loss drug prices and improve medication accessibility in America, the Trump administration also debuted the BALANCE scheme, which aims to offer insurer-fronted obesity medicines like Eli Lilly’s Zepbound (tirzepatide) and Novo Nordisk’s Wegovy (semaglutide) at $50 per month via Medicare and Medicaid. However, the Centers for Medicare and Medicaid (CMS) recently put a pilot of the BALANCE initiative on ice due to insurer pushback.
Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.
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