The Food and Drug Administration on Friday approved Regeneron Pharmaceuticals and Sanofi’s inflammatory disease drug Dupixent for a common lung condition. The decision could significantly expand use of what is already one of the industry’s best-selling medicines.
Dupixent is now cleared for use as an add-on maintenance treatment for adults with a certain kind of chronic obstructive pulmonary disease, or COPD, that can’t be controlled with other medications.
The decision makes Dupixent the first biologic medicine approved in the U.S. for COPD, a lung disease that makes it difficult to breathe and is typically treated with inhaled medicines. Regeneron estimates about 300,000 people in the U.S. have the specific type of COPD that would make them eligible for treatment with Dupixent, which is administered via 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 first reaching the U.S. market in 2017 as a treatment for eczema, Dupixent has now been cleared for six other diseases. Global sales reached almost $12 billion last year, and Sanofi has projected that number could climb further still as its use is broadened.
An approval in COPD has been viewed by Wall Street analysts as a way to meet those lofty projections. But the drug’s success in the disease wasn’t a sure thing, as biologics have historically struggled to treat COPD. The companies focused on a subset of COPD patients with Type 2 inflammation, a type of immune response Dupixent disrupts. They enrolled into a pair of late-stage trials nearly 1,900 people, all of whom were already receiving treatment with other COPD drugs. In both studies, Dupixent treatment was associated with a lower rate of “exacerbations,” when symptoms worsen, and improved lung function.
European regulators approved Dupixent for COPD in July, but Regeneron and Sanofi have had to wait longer in the U.S., 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 earlier this month succeeded in a Phase 3 trial. Others could join in the coming years, too, as biologic medicines from Roche and AstraZeneca are also in late-stage testing.
For Regeneron, which splits U.S. Dupixent revenue with Sanofi, the COPD approval is a needed boost. The company lost nearly $14 billion of its market value earlier this week after a setback in a court case that could allow Amgen to launch a biosimilar version of its eye drug Eylea sooner than investors expected. That decision made “uncertain” the future of the Eylea franchise, which still accounts for the bulk of Regeneron’s revenue, wrote Leerink Partners analyst David Risinger in a Tuesday note to clients.
It also heightened pressure on the rest of Regeneron’s pipeline, which includes medicines for cancer, obesity and another Sanofi-partnered drug, itepekimab, that’s in late-stage testing for asthma and COPD.
“Although the innovation behind the company’s pipeline is exciting, we view the product profiles and commercial
prospects for a number of programs as TBD,” Risinger wrote.
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- Source: https://www.biopharmadive.com/news/dupixent-copd-fda-approval-regeneron-sanofi/727726/