FDA approves COPD drug Regeneron and Sanofi after delay

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The Food and Drug Administration on Friday approved Regeneron Pharmaceuticals and Sanofi's inflammatory drug Dupixent for a common lung disease. The decision could significantly expand the use of one of the industry's already best-selling drugs.

Dupixent is now approved as an adjunctive maintenance treatment for adults with a certain type of chronic obstructive pulmonary disease (COPD) that cannot be controlled with other medications.

The decision makes Dupixent the first biologic drug approved in the U.S. for COPD, a lung disease that makes breathing difficult and is typically treated with inhaled medications. Regeneron estimates that about 300,000 people in the United States have the specific type of COPD that would be eligible for treatment with Dupixent, which is administered by injection under the skin.

The clearance is expected to further boost sales of Dupixent, which is a key source of revenue for both Sanofi and Regeneron. Since Dupixent first hit the U.S. market in 2017 to treat eczema, it has now been approved for six other conditions. Global sales reached nearly $12 billion last year, and Sanofi has predicted that number could rise even further as its use expands.

An approval for COPD was seen by Wall Street analysts as a way to meet these lofty projections. However, the drug's success in the disease was not certain because biologics have had difficulty treating COPD in the past. The companies focused on a subset of COPD patients with type 2 inflammation, a type of immune response that interferes with Dupixent. They participated in two late-stage studies involving nearly 1,900 people, all of whom were already being treated with other COPD medications. In both studies, treatment with Dupixent was associated with a lower rate of “exacerbations,” where symptoms worsened, and improved lung function.

European regulators approved Dupixent for COPD in July, but Regeneron and Sanofi had to wait longer in the US, where the FDA requested additional efficacy data from the two trials. Over that time, a potential new competitor has emerged in GSK's Nucala, which the FDA rejected in 2018 but was successful in a Phase 3 trial earlier this month. Others could be added in the coming years, as biologics from Roche and AstraZeneca are also in late-stage testing.

For Regeneron, which splits Dupixent's U.S. revenue with Sanofi, the COPD approval is a needed boost. The company lost nearly $14 billion of its market value earlier this week after suffering a setback in a lawsuit that could allow Amgen to bring a biosimilar version of its eye drug Eylea to market sooner than investors expected. That decision makes the future of the Eylea franchise, which still accounts for the majority of Regeneron's revenue, “uncertain,” Leerink Partners analyst David Risinger wrote in a note to clients Tuesday.

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It also increased pressure on the rest of Regeneron's pipeline, which includes drugs for cancer and obesity as well as another Sanofi partner drug, itepekimab, which is in late-stage testing for asthma and COPD.

“While the innovation behind the company's pipeline is exciting, we look at the product profiles and commercials
Prospects for a number of programs as TBD,” Risinger wrote.