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Pharma companies wishing to reap the benefits of the programme need to demonstrate US-centric potential for their drug candidates. kemalbas via GettyImages. The US Food and Drug Administration (FDA) has selected the first products to be included on the Commissioner’s National Priority Voucher (CNPV) pilot programme. A total of nine drug candidates have joined the scheme launched in June 2025 , which will see its developers receive a voucher that will significantly expedite their path to approval. The group is headed by Merck’s Pergoveris (follitropin alfa/lutropin alfa), which is already approved in Europe, for the treatment of infertility. President Donald Trump specifically identified Pergoveris’ inclusion, touting the drug’s potential to offer a cheaper option to US patients. “This drug would directly compete against a much more expensive option that currently has a monopoly in the American market, and this will bring down costs very significantly,” Trump said during an IVF news conference at the White House. Trump was likely referring to Gonal-f, made by Merck’s US and Canadian healthcare business EMD Serono. Gonal-f generated global sales of €833m in 2024. The pharma company plans to use its CNPV to file for FDA approval of its new drug, which it disclosed while announcing a broader deal with the US government to expand fertility access treatment. Elsewhere on the list, candidates being developed for hearing and vision loss have been included in the form of Regeneron’s gene therapy DB-OTO and Dompé Farmaceutici’s Oxervate (cenegermin-bkbj), respectively. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence Sanofi’s teplizumab, which is already FDA-approved to delay the onset of stage 3 type 1 diabetes, has been included on the list. The agency said it was selected for “type 1 diabetes,” hinting that the review could be for a broader label approval. Revolution Therapeutics’ RMC-6236, in development for the treatment of pancreatic cancer, and Disc Medicine’s porphyria therapy bitopertin round off the list of products for specific diseases. The FDA selected cytisinicline for nicotine vaping addiction, while ketamine and Augmentin XR were chosen to boost domestic manufacturing of anaesthesia and antibiotics, respectively. The CNPV programme is the latest move by the Trump administration to bolster its pharmaceutical armoury and incentivise the development of new drugs specifically for Americans . Pharma companies wishing to reap the benefits of the programme need to demonstrate US-centric potential for their drug candidates. Therapies need to address a health crisis in the country, produce an innovative cure for American patients, meet public health needs, or increase domestic drug manufacturing as a national security issue. In its statement sharing the first batch of recipients, the FDA said that each product has significant potential to address one or more of these major national priorities. The agency stated that it would likely add another group of CNPV recipients in the coming months. Companies with a product in the programme will receive a decision within 1-2 months, compared to the usual 10-12 months, following filing of a complete application for a drug or biologic. Sponsors will also be able to undertake enhanced feedback with FDA staff during development and the review window. “One of our core goals is to deliver more cures and meaningful treatments – especially ones that have an outsized impact on our most pressing national priorities. We must modernise the review process and try new approaches to meet the needs of the American people,” said FDA commissioner Marty Makary. While the CNPV pilot begins its journey in the US regulatory landscape, experts have been concerned that its activity could take attention away from similar programmes that incentivise rare diseases. Pharmaceutical Technology Excellence Awards - The Benefits of Entering Gain the recognition you deserve! The Pharmaceutical Technology Excellence Awards celebrate innovation, leadership, and impact. By entering, you showcase your achievements, elevate your industry profile, and position yourself among top leaders driving pharmaceutical advancements. Don’t miss your chance to stand out—submit your entry today! Nominate Now

Merck KGaA is the latest drugmaker to slash some of its products' US list prices in exchange for an exemption from President Donald Trump's 100% pharmaceutical tariff — and one of the first to receive a new kind of speedy review voucher from the FDA.The third pharma to reach a most-favoured nation (MFN) drug pricing deal with the Trump administration, Merck — through its US-based healthcare business unit, EMD Serono — will make its in vitro fertilization (IVF) therapies available through a direct-to-consumer (DTC) platform that patients with prescriptions will be able to reach via the government-run TrumpRx website, due to launch in January. The company said on Thursday that if all three of its IVF offerings — Gonal-f (follitropin alfa injection), Ovidrel (choriogonadotropin alfa injection) and Cetrotide (cetrorelix acetate for injection) — are used in a single IVF protocol, patients will pay 84% less than the total list price. While AstraZeneca's and Pfizer's respective MFN deals earned them each a three-year grace period from tariffs, Merck said in a release that its pharmaceutical products and ingredients will be excluded from tariffs, without a time limit, "provided EMD Serono invests in future biopharmaceutical manufacturing and research in the United States."The German drugmaker "look[s] forward to growing our footprint here even further with future fertility manufacturing," said Belén Garijo, CEO and chair of Merck, in a company release.A new kind of priority reviewAnd more fertility options for US patients are on the way. In conjunction with the MFN deal, Merck also announced that it's part of the inaugural cohort of companies to receive one of the FDA's new Commissioner’s National Priority Vouchers (CNPVs). The pharma plans to use its voucher to accelerate review of Pergoveris, an IVF therapy that combines recombinant human follicle stimulating hormone (r-hFSH) and recombinant human luteinizing hormone (r-hLH) in a single injection pen. The product has been approved in Europe since 2017. With the CNPV, Merck is promised a regulatory decision on Pergoveris within one to two months after filing the application, along with "enhanced" communication with FDA staff during the review process. The US regulator had said in June it planned to start handing out CNPVs to drugmakers "addressing our most important US national priorities," either by attempting to solve a health crisis, upping domestic manufacturing or developing an innovative treatment. In July, FDA Commissioner Marty Makary suggested that companies that promise to "equalise" the cost of their drugs between the US and other countries could also qualify for a CNPV.In addition to Merck's Pergoveris, the FDA on Thursday revealed eight other products that have earned a CNPV, including Regeneron's hearing loss gene therapy DB-OTO; the company had announced plans to file for FDA approval of the one-time treatment just days earlier.Another CNPV went to Sanofi's anti-CD38 antibody teplizumab to treat type 1 diabetes. Initially approved by the FDA in 2022 to delay the onset of stage 3 type 1 diabetes in adults and children aged 8 years and older who have stage 2 disease, the French pharma gained teplizumab through its $2.9-billion takeout of Provention Bio in 2023.Revolution Medicines has snagged a voucher for pancreatic cancer treatment daraxonrasib (RMC-6236); it started a registrational trial of the pan-RAS inhibitor in October 2024. Disc Medicines will get a fast review for bitopertin, having just submitted an application on Sept. 30 for the oral GlyT1 inhibitor to treat erythropoietic protoporphyria, including X-linked protoporphyria.FDA approved for neurotrophic keratitis in 2018, Dompé Farmaceutici's cenegermin received a voucher for blindness. Other recipients include Achieve Life Sciences' nicotine vaping addiction treatment cytisinicline, as well as domestically manufactured versions of ketamine and Augmentin XR, an antibiotic.