logo
  

Sanofi Says Second Phase 3 Dupixent Trial Confirms Improvements For Patients With Prurigo Nodularis

A second Phase 3 trial, PRIME, which evaluated Dupixent (dupilumab) in adults with uncontrolled prurigo nodularis, a chronic type 2 inflammatory skin disease, met its primary and key secondary endpoints. The trial result showed that Dupixent significantly reduced itch and skin lesions compared to placebo at 24 weeks in the investigational setting, Regeneron Pharmaceuticals Inc. (REGN) and Sanofi (SNYNF,SNY) said in a statement.

Prurigo nodularis is a chronic inflammatory skin disease where an extremely itchy, symmetrically distributed rash appears most commonly on the arms, legs, the upper back and/or the abdomen. The itch associated with Prurigo nodularis is so severe that it often interferes with sleep and psychological wellbeing.

The phase 3 data confirmed results from first Phase 3 trial, with 60% of Dupixent patients meeting the primary endpoint of itch reduction compared to 18% of placebo at 24 weeks. The data will be submitted to regulatory authorities around the world starting in the first half of this year, the companies said.

Dupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in atopic dermatitis, asthma and chronic rhinosinusitis with nasal polyposis.

Dupixent is currently approved in the U.S., Europe, Japan and other countries around the world for use in specific patients with moderate-to-severe atopic dermatitis, as well as certain patients with asthma or chronic rhinosinusitis with nasal polyposis in different age populations.

Dupixent is also approved in one or more of these indications in more than 60 countries around the world, and more than 350,000 patients have been treated globally.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Ryanair Holdings Plc reported Monday a loss in its fiscal year 2022, narrower than last year, with strong growth in traffic and load factor. Looking ahead, the company said it expects to return to reasonable profitability in fiscal 2023. Shares of the low fares airline were losing around 4 percent in the morning trading in Germany. The U.S. Department of Agriculture's Food Safety and Inspection Service or FSIS has issued a public health alert against Weis Markets' ready-to-eat or RTE General Tso Chicken meals due to misbranding and undeclared milk, a known allergen. The RTE General Tso Chicken meals were prepared, labeled and sold in the Deli area at Weis Markets stores between April 13 and May 11, 2022. Deutsche Telekom AG on Friday raised its fiscal 2022 adjusted earnings forecast after reporting significantly higher net profit in its first quarter. Shares of the German telecom major were gaining around 1 percent in the morning trading in Germany. For fiscal 2022, the company now expects to post adjusted EBITDA AL of more than 36.6 billion euros.
Follow RTT