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Sanofi SNY and partner Regeneron REGN announced that the FDA has accepted their supplemental biologics license application (sBLA) seeking approval for Dupixent for treating bullous pemphigoid (BP), a chronic, debilitating and relapsing skin disease.
With the FDA granting a priority review status to the sBLA, a decision is expected by June 20, 2025.
The sBLA is based on data from a pivotal study that demonstrated that Dupixent led to significant improvements in sustained disease remission compared to placebo in adult patients with moderate-to-severe BP.
Sanofi’s stock has risen 18% in the past year against a decrease of 7.9% for the industry.
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BP is an inflammatory skin condition primarily occurring due to type 2 inflammation. The disease, which mostly occurs in older adults, is characterized by large fluid-filled blisters on the skin which can be itchy and painful, reddening of the skin and painful lesions. If approved for BP, Dupixent will become the first medicine approved as a targeted treatment for BP in the United States. At present, there is no targeted cure for BP and corticosteroids, immunosuppressants and antibiotics are prescribed to relieve symptoms and prevent new blisters from forming.
Dupixent – Key Top-Line Driver for SNY & REGN
Dupixent is now approved in several countries, including the United States and EU, for six type II inflammatory diseases, namely severe chronic rhinosinusitis with nasal polyposis, severe asthma, moderate-to-severe atopic dermatitis, eosinophilic esophagitis, prurigo nodularis and chronic obstructive pulmonary disease.
It is being jointly marketed by Regeneron and Sanofi under a global collaboration agreement. Sanofi records global net product sales of Dupixent, while Regeneron records its share of profits/losses in connection with the global sales of the drug.
The drug is a key top-line driver for both Sanofi and Regeneron on strong demand trends. Dupixent’s strong sales growth is being driven by demand across all geographies, newly approved indications and demographics. New uses, increased penetration in approved indications and further geographic expansion are expected to drive Dupixent’s sales in future quarters.
An sBLA seeking approval of Dupixent for chronic spontaneous urticaria is also under review in the United States and EU. A decision in the United States on this sBLA is expected on April 18. Phase III studies are ongoing on Dupixent for chronic pruritus of unknown origin and lichen simplex chronicus.
In 2024, Dupixent generated global product sales of $€13.07 billion ($14.15 billion), which were recorded by Sanofi, representing growth of 23.1% at a constant exchange rate. Sanofi expects Dupixent to achieve around €22 billion in sales in 2030.