FDA seeks more data on Dupixent COPD clinical trials

Review could delay approval decision by three months

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by Lindsey Shapiro PhD |

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The U.S. Food and Drug Administration (FDA) has asked for more data from clinical trials that tested Dupixent (dupilumab) in people with chronic obstructive pulmonary disease (COPD), Regeneron Pharmaceuticals, one of the therapy’s developers, announced during a company webcast.

The requested data pertains to subgroup analyses from two similarly designed Phase 3 trials —  BOREAS (NCT03930732) and NOTUS (NCT04456673) — whose data mainly supported the regulatory application seeking an expansion of Dupixent’s current label to include certain adults with COPD.

The application, filed by developers Regeneron and Sanofi, was placed under priority review in February, with a decision expected by June 27.

“During its review of our submission, the FDA has requested additional efficacy analyses, including an information request received earlier this week regarding subpopulations from the BOREAS and NOTUS pivotal studies,” Leonard Schleifer, MD, PhD, president and CEO of Regeneron, said in a webcast announcing first-quarter financial results.

“While the FDA has requested these analyses be submitted by the end of May, we anticipate providing them substantially sooner,” Schleifer said, adding that should the agency need more time to review those results, the decision date could be pushed back by as long as three months.

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Dupixent could help COPD lung inflammation

Dupixent is a biological therapy, meaning that it uses molecules made from living organisms, that works by suppressing two inflammatory signaling molecules believed to drive type 2 inflammation.

This type of inflammation is characterized by an elevation in the blood of immune cells called eosinophils, and is thought to contribute to lung inflammation in COPD.

Dupixent is already approved in the U.S. for five other conditions characterized by type 2 inflammation. If approved, the label expansion would cover Dupixent’s use as an add-on therapy for adults with uncontrolled COPD and evidence of type 2 inflammation.

The BOREAS and NOTUS trials each involved more than 900 current or former smokers with COPD who had signs of type 2 inflammation and uncontrolled disease despite use of standard inhaled therapy.

Participants were randomly assigned to receive either Dupixent or a placebo via an under-the-skin injection once every two weeks while continuing on inhaled therapies.

In both trials, Dupixent led to significant reductions in moderate or severe COPD exacerbations compared with placebo over a year of treatment, as well as rapid and sustained lung function improvements, meeting the main and key secondary goals.

Side effects were consistent with the known therapy’s profile in other indications. Side effects that were reported more frequently with Dupixent than a placebo included back pain, COVID-19, diarrhea, headache, and the common cold.

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Schleifer indicated that the subgroup analyses requested by the FDA similarly reflect the benefits of Dupixent across patient groups.

“Our analyses across these requested patient subgroups indicate a consistent and clinically meaningful reduction in COPD exacerbations,” Schleifer said, noting that the companies are “confident” that these findings will support Dupixent’s approval for COPD.

“We and our partner Sanofi are preparing for a launch that many pulmonologists, respiratory key opinion leaders, and patients are eagerly anticipating,” Schleifer said. 

If the FDA clears it, Dupixent will become the only biologic therapy available for COPD patients, and the first new COPD treatment in more than a decade, the CEO noted.

“If approved, we’ll work to rapidly establish the unique clinical benefits of Dupixent, activate physician adoption, motivate patients to seek treatment, and also advance access and affordability,” said Marion McCourt, executive vice president and head of commercial at Regeneron. 

According to Schleifer, there would be about 300,000 patients eligible for the medication in the U.S. and another 300,000 in the European Union (EU) and Japan, where regulatory applications are also underway or in planning. A decision in the EU is expected in the second half of 2024.