Sanofi and Regeneron will have to wait three more months for a major FDA decision on expanding Dupixent’s label, the companies disclosed Friday morning. Meanwhile, European authorities have recommended its approval in the same indication.
The regulatory clearance for Dupixent as an add-on maintenance treatment for certain patients with chronic obstructive pulmonary disease has been closely watched. The anti-inflammatory antibody, which is already approved for other diseases like atopic dermatitis and asthma, is poised to be the first biologic approved for patients with COPD and the “first new treatment approach” in more than a decade, executives have said. The FDA had granted the treatment priority review.
Regeneron warned investors about the potential US delay in early May when the FDA requested more efficacy analyses on the Phase 3 trials that formed the basis of their filing. Now, the agency has decided that the additional information amounts to a “major amendment to the sBLA” and wants more time to review it.
The deadline is now pushed from June 27 to Sept. 27.
In a statement, Sanofi and Regeneron emphasized that the FDA “did not raise any concerns regarding the approvability of Dupixent for this indication,” and that they remain confident that the additional analyses “strongly support” approval.
By inhibiting the IL-4 and IL-13 pathways, Dupixent is said to tamp down type 2 inflammation. In the Phase 3 COPD studies, the drug cut exacerbations and improved lung function for patients whose disease was uncontrolled despite being on standard-of-care treatment.
Those results were enough to convince the EMA’s Committee for Medicinal Products for Human Use to adopt a positive opinion, setting up a final approval decision by the European Commission over the next few months.