FDA Approves Dupixent by Regeneron and Sanofi for Bullous Pemphigoid Treatment

Regeneron and Sanofi Receive Approval for the Medication

Image Credits: FirstWord Pharma

Announcement

Sanofi and Regeneron Pharmaceuticals, Inc. received approval for Dupixent (dupilumab), a medication for adults suffering from bullous pemphigoid (BP). The approval of this medication was based on certain results confirming a successful improvement in disease and reduction in oral corticosteroid and itch. The medication is approved to treat eight diseases in the US. This is an additional advancement to the healthcare market.

About BP

The BP is a debilitating, relapsing, and chronic skin disease that affects 27,000 adults in the US. The thousands of patients are not even managed with systemic corticosteroids. BP mainly affects geriatric populations and is identified by symptoms such as lesions, intense itch and painful blisters, also redness on the skin. This can even consist of type 2 inflammation. The rash and the blisters can cause much damage to the body, like breakdown and bleeding. This turns into a severe infection, disturbing daily functioning. Treatment options are limited, and so it might lower the patient's immune system due to the overall stress of the disease.

FDA Approval Terms and Conditions

The FDA approval is based on the evaluation of the data received from the ADEPT Phase 2/3 trial, calculating the safety and efficacy of Dupixent in comparison to placebo in adults having moderate-to-severe BP. Patients were selected to receive either a placebo (n=53) or Dupixent 300 mg (n=53), also standard of care oral corticosteroids (OCS). Patients went through protocol-defined OCS during treatment to see whether the control of disease activity was well maintained or not. The accurate analysis was updated during the FDA review.

Dupixent was under priority review, which was reserved for medicines that are effective for severe conditions. Dupixent was previously granted an orphan drug designation by the FDA for BP. The regulatory applications for the same are under review globally, including China, the EU, and Japan.

Views and Statements

Executive Director at the International Pemphigus and Pemphigoid Foundation, Patrick Dunn, said, “Individuals affected by bullous pemphigoid encountered painful blisters and itching. By now, the major elderly patients have limited therapeutic options with side effects that double the burden. With the approval of Dupixent for BP, a novel treatment has been introduced."

MD Phd, board co-chair, president and chief scientific officer at Regeneron, and a principal inventor of Dupixent, George D. Yancopoulos, said, “The approval has extended Dupixent’s ability to transform an innovative treatment for individuals suffering from various diseases under type 2 inflammation. It heals common conditions such as atopic dermatitis and asthma, also rare diseases like prurigo nodularis and eosinophilic esophagitis, and now BP.”