Regeneron and Sanofi's COPD Treatment Gains FDA Approval Following a Prolonged Delay

Regeneron and Sanofi’s COPD Treatment Gains FDA Approval Following a Prolonged Delay

Regeneron and Sanofi's COPD Treatment Gains FDA Approval Following a Prolonged Delay

On Friday, the FDA granted approval to Dupixent, an inflammatory disease medication developed by Regeneron Pharmaceuticals and Sanofi, for a prevalent lung ailment. This approval could greatly increase the usage of one of the top-selling drugs in the pharmaceutical sector.

Dupixent is now authorized as an additional maintenance therapy for adults suffering from a particular type of chronic obstructive pulmonary disease (COPD) that remains uncontrolled by existing medications.

This decision marks Dupixent as the inaugural biologic medication sanctioned in the U.S. for COPD, a disorder that complicates breathing and is traditionally managed with inhalation therapies. Estimates suggest around 300,000 individuals in the U.S. have this specific variant of COPD that qualifies for Dupixent treatment, which is delivered through subcutaneous injection.

The approval is anticipated to enhance Dupixent’s sales further, which already serves as an essential revenue stream for both Sanofi and Regeneron. Since its U.S. launch in 2017 for eczema treatment, Dupixent has received approval for six other conditions. Last year, global sales approached billion, with Sanofi projecting continued sales growth with the medication’s expanded applications.

An endorsement for COPD is regarded by Wall Street analysts as a pathway to fulfill these ambitious sales forecasts. However, the drug’s effectiveness in treating COPD was uncertain, as biologics have often had limited success with this condition. The companies concentrated on a cohort of COPD patients exhibiting Type 2 inflammation, a form of immune response that Dupixent disrupts. In two late-stage trials, nearly 1,900 participants, already on other COPD treatments, were enrolled. In these trials, treatment with Dupixent resulted in reduced “exacerbations,” or periods when symptoms intensify, and improved lung function.

While European regulators approved Dupixent for COPD in July, the companies faced delays in the U.S. as the FDA requested more efficacy data from the studies. Meanwhile, a potential rival, GSK’s Nucala, which was previously rejected by the FDA in 2018, showed success in a recent Phase 3 trial earlier this month. Other competitors, including biologics from Roche and AstraZeneca, may enter the market in the coming years, as they are also undergoing late-stage evaluations.

For Regeneron, which collaborates with Sanofi on U.S. Dupixent revenues, the approval for COPD represents a much-needed enhancement. The company’s market value dropped by nearly billion earlier this week following a legal hurdle that may permit Amgen to launch a biosimilar version of its eye medication, Eylea, sooner than anticipated. This ruling cast doubt on the future viability of the Eylea portfolio, which remains a significant revenue contributor for Regeneron, according to analyst David Risinger from Leerink Partners.

This situation has increased the scrutiny on the rest of Regeneron’s drug pipeline, which encompasses treatments for cancers, obesity, and another Sanofi-partnered medication, itepekimab, currently in late-stage trials for asthma and COPD.

“While the innovation behind the company’s pipeline is promising, we deem the product profiles and commercial prospects for several programs as still to be determined,” commented Risinger.