Sanofi leans on COPD as 'next major growth pillar' for its immunology star Dupixent: CEO

Even as new Sanofi drugs like Beyfortus and Altuviiio come into their own, the French pharma’s immunology powerhouse Dupixent shows no signs of slowing down. In fact, Sanofi is already gearing up for the antibody’s potential debut in what CEO Paul Hudson dubbed the drug’s “next major growth pillar.”

Sanofi is preparing to launch Dupixent in chronic obstructive pulmonary disease (COPD) “as early as late June,” Hudson said on an analyst call Thursday. The FDA is set to rule on Dupixent’s merits in COPD on June 27. The approval would mark Dupixent’s sixth U.S. indication behind those for atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis and prurigo nodularis.

Dupixent already has a strong reputation with pulmonologists thanks to the drug’s asthma and rhinosinusitis nods, Hudson noted. Still, the CEO caveated that it would take some time to drive awareness and diagnosis of COPD with type 2 inflammation, and, as a result, the “inflection of sales growth [for Dupixent in COPD] is likely to come in 2025.”

Should the approval come through, Hudson said he was confident that “COPD will become the next major growth pillar for Dupixent.”

Back in November, Sanofi and Regeneron’s Dupixent triumphed in a second phase 3 study in COPD, potentially teeing up Dupixent’s approval as the inaugural biologic to treat the lung disease and the first major advancement in the indication in more than a decade.

Results from the NOTUS study showed that patients on Dupixent, compared to those on placebo, experienced a 34% reduction in COPD exacerbations that needed additional treatment. The antibody also produced significant lung function improvement within 12 weeks, which remained intact through 52 weeks.

Meanwhile, Sanofi is also developing another antibody against COPD—itepekimab—and together with Dupixent, the two COPD drugs could clinch combined peak sales of roughly 5 billion euros in that indication, Hudson pointed out.

Hudson made his remarks on Dupixent’s potential COPD launch as the drug grew sales 25% to 2.8 billion euros (around $3 billion) in 2024’s first quarter. That performance has cemented Sanofi’s thesis that Dupixent could reach roughly 13 billion euros ($13.9 billion) in sales for the entire year, Hudson said.

Aside from the potential COPD nod, Dupixent has benefited from label expansions in markets beyond the U.S. as well, the CEO pointed out.

In February, for instance, Japan became the first country to sign off on Sanofi’s anti-inflammatory blockbuster in chronic spontaneous urticaria (CSU), which causes sudden hives, deep swelling under the skin and persistent itch. There are approximately 110,000 people in Japan who suffer from uncontrolled moderate-to-severe CSU, Sanofi noted at the time.

And in the U.S., Dupixent in late January expanded its label in eosinophilic esophagitis to include kids between the ages of 1 and 11 who weigh at least 33 pounds. The company’s original approval in that indication came in May of 2022 and included patients ages 12 and up.

According to Hudson, there are now more than 850,000 patients on Dupixent worldwide, with strong sales contributions coming from the likes of Japan, China and Germany.

Beyond Dupixent, Sanofi’s roster of new products, including the AstraZeneca-partnered respiratory syncytial virus (RSV) immunization Beyfortus, generated close to a billion euros in sales for the quarter, comprising 9% of the company’s total biopharma business, Hudson said.

Amid “enthusiastic demand” for Beyfortus, Sanofi and AZ are working to expand the manufacturing network for their RSV antibody, the CEO explained.

“We’re confident that we will meet anticipated customer demand and look forward to extending all infant protection programs in the upcoming northern hemisphere RSV season,” Hudson said.

All told, Sanofi reaped roughly 10.5 billion euros (about $11.2 billion) in total sales for 2024’s first quarter, signaling 6.7% growth at constant exchange rates over the sum the company generated over the same stretch in 2023.