EMD Serono announced its agreement with the US government to expand access to its pipeline of in vitro fertilization (IVF) therapies for upwards of 10 million women struggling with fertility in the US. As part of the agreement, Serono is offering direct-to-consumer (DTC) sales of its entire IVF portfolio, which includes Gonal-f, Ovidrel, and Cetrotide.¹ According to a news release from EMD Serono, the company is extending this offer to eligible patients with prescriptions at “significantly” reduced prices, and when all three therapies are used in standard IVF protocol, it will enable patients to receive up to an 84% discount from list price.¹

“As a result of our collaboration with President Trump and his Administration, more families across the United States can now access and benefit from IVF innovation and hopefully fulfill their dream of starting or expanding their family,” said Danny Bar-Zohar, CEO healthcare and member of the executive board of Merck KGaA, Darmstadt, Germany. “Gonal-f is the most prescribed follicle stimulating hormone in the U.S., and our full portfolio of IVF therapies has supported over 6 million successful births worldwide. Looking forward, we will continue to address complex fertility issues for patients in the U.S. with the FDA filing of Pergoveris, through the FDA Commissioner's National Priority Voucher program.”

What else is included in the agreement?

Along with the agreement, Serono announced its decision to participate in the TrumpRx.gov direct purchasing platform, which is expected to go live in 2026.¹ The company also announced that patients will have access to Serono’s fertility medicines through the company's existing pharmacy network, and through an expanded network in January 2026. Serono also entered an agreement with the US Secretary of Commerce, excluding its pharmaceutical products and ingredients from Section 232 tariffs, as long as Serono invests in future biopharmaceutical manufacturing and research in the United States.¹ This public-private partnership is aligned with the White House Executive Order aiming to increase affordable access to IVF treatments.¹

"We have a strong presence in the U.S. across all three of our business sectors, with a significant number of our employees based in this key market and look forward to growing our footprint here even further with future fertility manufacturing,” said Belén Garijo, chair of the executive board and CEO of Merck KGaA, Darmstadt, Germany. “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."

EMD Serono planning to file Pergoveris for review

In order to expand its therapeutics options for patients suffering from complex fertility complications, Serono announced its plan to file Pergoveris for review under the FDA Commissioners National Priority Voucher (CNPV) program, which is designed to expedite the drug review process for products aligning with US national health priorities, and reduces review times from ten to twelve months, to just one to two months.According to a news release from EMD Serono, Pergoveris meets all the criteria to entire the program.¹

FDA recently announced that Pergoveris is one of the first nine recipients to be approved for the CNPV program, and will receive enhanced communications with review staff throughout the development process prior to their final submission and during the review period.² According to a press release from FDA, if necessary, FDA scientists reserve the right to extend the review time if an application is incomplete, there are manufacturing violations, or as they otherwise deem appropriate.²

President Trump commented on Pergoveris’ acceptance into the program, saying, "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."

The following are all nine of the accepted products under review in the CNPV program.

• Pergoveris
• Teplizumab
• Cytisinicline
• DB-OTO
• Cenegermin-bkbj
• RMC-6236
• Bitopertin
• Ketamine
• Augmentin XR

Sources

1. EMD Serono Announces Unprecedented Agreement with U.S. Government to Expand Access to IVF Therapies EMD Serono October 16, 2025 https://www.businesswire.com/news/home/20251016665136/en/EMD-Serono-Announces-Unprecedented-Agreement-with-U.S.-Government-to-Expand-Access-to-IVF-Therapies
2. FDA Awards First-Ever National Priority Vouchers to Nine Sponsors U.S. Food and Drug Administration October 16, 2025 https://www.fda.gov/news-events/press-announcements/fda-awards-first-ever-national-priority-vouchers-nine-sponsors