Follitropin Alfa (Merck)

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’s U.S. arm EMD Serono is the latest to join President Donald Trump's most-favored nation pricing push, following AstraZeneca and Pfizer. Merck KGaA’s U.S. arm EMD Serono is joining President Donald Trump’s most-favored nation drug pricing push with an agreement to sell its fertility therapies at a sharp discount through the government’s TrumpRx direct-to-consumer purchasing platform.The company will offer its full in vitro fertilization (IVF) drug portfolio, including Gonal-f, Cetrotide and Ovidrel, to eligible patients, with an 84% discount for the use of all three therapies in a typical IVF regimen when TrumpRx goes live in 2026. Citing the Centers for Medicare & Medicaid Services, the White House said the price cuts could save patients up to $2,200 per IVF cycle. Fertility medications make up almost 20% of the total cost of treatment, which can total between $15,000 and $30,000 for one round, according to GoodRx. The new public-private partnership with EMD Serono complies with Trump’s February executive order on expanding access to IVF, the company said in a Thursday press release. The White House said EMD Serono will offer other drugs at deep discounts when sold directly to patients and guarantee MFN prices on new medicines, while the company separately said it reached a Commerce Department agreement to exclude its products from Section 232 tariffs in return for U.S. manufacturing and research investments.EMD Serono already has a strong U.S. presence and looks “forward to growing our footprint here even further with future fertility manufacturing,” CEO of Merck KGaA, Darmstadt, Germany’s Belén Garijo said in the company's release.“We are committed to working with the U.S. administration to add value over the long term, ensuring that our patients and customers continue to have access to and benefit from the innovations within our portfolio,” Garijo added.According to the White House, the agreement marks the “first time in history” that EMD Serono is investing in U.S. manufacturing. The company has long operated in the U.S. and moved its headquarters to Boston in 2023.EMD Serono’s Gonal-f was first approved in the late 90s as one of the first recombinant human products used to treat infertility. Since then, the Merck KgaA unit has built out its fertility franchise to include other complementary products and devices, with the next addition now coming to the U.S. sooner, with a potential FDA Commissioner’s National Priority Voucher (CNPV).CNPV for IVF  The company’s Pergoveris, a combination of recombinant human follicle-stimulating hormone (r-hFSH) and recombinant human luteinizing hormone (r-hLH) that’s designed to “mimic reproductive physiology,” will soon be filed for FDA review under its CNPV program. The program applies to products that align with U.S. national health priorities and reduces the FDA’s review timeline from about 10 to 12 months to one to two months. FDA Commissioner Marty Makary, M.D., launched the CNPV program in June and announced the first nine recipients on Oct. 16. Other than EMD Serono’s Pergoveris for infertility, investigational products from Regeneron, Sanofi and others made the cut to treat diseases ranging from diabetes, deafness and blindness, to name a few.Pergoveris is already widely available outside the U.S. If it wins U.S. approval, the White House said patients could benefit further from lower prices thanks to increased competition in the fertility drug market.Along with the administration’s deal with EMD Serono, it announced new guidance for employers to offer standalone benefit packages for IVF and infertility. One in 8 U.S. couples struggles with fertility, according to EMD Serono, which describes itself as “the leader in fertility therapeutics.”EMD Serono joins AstraZeneca and Pfizer in complying with Trump’s MFN pricing demands, which look to tie U.S. prices to lower costs overseas. Much of the deal implores companies to sell their drugs directly to patients, which many have already embraced. Others, like Bristol Myers Squibb, will roll out their drugs in the U.K. at higher U.S.-linked prices.