With a White House drug pricing deal done and dusted and the threat of tariffs ameliorated, Sanofi is enjoying more clarity from the U.S. government now than the same time last year. But several concerns still linger for the French pharma as the calendar turns to 2026.
The company’s “most favored nation” pricing deal “was a very difficult needle to thread,” CEO Paul Hudson told reporters at a Wednesday media event in San Francisco during the J.P. Morgan Healthcare Conference.
“I don't want to give the impression that there's no impact from MFN, because there is,” the Sanofi leader said. “The question for us is, can we manage that and deliver an attractive long-range plan. We feel, so far, we can.”
The administration’s ongoing assault on vaccination is another shadow looming on the horizon for Sanofi. The pharma’s prophylactic antibody for respiratory syncytial virus, Beyfortus, is currently being scrutinized by the FDA. Meanwhile, the CDC recently limited its recommendation for childhood RSV immunization to kids at high-risk and those with unvaccinated mothers as part of an unprecedented overhaul of the childhood vaccine schedule in the U.S.
The scrutiny comes amid a “broader question about [the] risk-benefit” of vaccines, Sanofi R&D chief Houman Ashrafian, Ph.D., said during the event. On this front, Sanofi’s large dataset should speak for itself, he argued.
“There is randomized controlled trial data, but much more importantly, large real-world studies in multiple jurisdictions, which have confirmed not only the obvious benefits related to hospitalization and reduction of infection, but also ancillary benefits,” Ashrafian said.
The vaccine policy changes are not far afield from what Sanofi expected in the run-up to the election, Hudson added.
“I've had conversations with Kennedy, we just try to stick to the facts,” Hudson explained. “Not much we can do.”
The FDA threw another curveball at Sanofi earlier this month when it rejected BTK inhibitor tolebrutinib for multiple sclerosis. The agency highlighted concerns over liver toxicity, including a patient death, and also said that the drug’s benefit was not clearly established. Sanofi, unsurprisingly, disagrees.
“There's extraordinary efficacy data, but you had to monitor the liver for the first 90 days,” Hudson said. “If you ask patients, that's a trade they would take.”
At the time of the rejection, Ashrafian called the snub “a significant and meaningful change in direction from the feedback the agency previously provided to Sanofi.”
With further surprises from the Trump administration almost guaranteed this year, Sanofi is gearing up for the road ahead with more than 300 meetings at JPM, Hudson said, including “speed dating” rounds with “small biotechs that we're establishing relationships with.”
“We're happy to be here, I guess, and making as much progress as we possibly can after an important year,” the CEO said.