Cetrorelix

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.