logo
Plus   Neg
Share
Email

Regeneron Says CHMP Recommends Approval Of Dupixent For Asthma Indication

Regeneron Pharmaceuticals, Inc. (REGN) and Sanofi announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Dupixent (dupilumab) in asthma.

The CHMP recommended Dupixent be approved for use in adults and adolescents 12 years and older as add-on maintenance treatment for severe asthma with type 2 inflammation characterized by raised blood eosinophils and/or raised fractional exhaled nitric oxide (FeNO), who are inadequately controlled with high dose inhaled corticosteroid plus another medicinal product for maintenance treatment.

Dupixent is a human monoclonal antibody that inhibits the signaling of interleukin-4 (IL-4) and interleukin-13 (IL-13), two key proteins that play a central role in type 2 inflammation that underlies specific types of asthma as well as several other allergic diseases. This effect is associated with the reduction of type 2 inflammatory biomarkers including FeNO, immunoglobulin E (IgE) and eotaxin-3 (CCL26).

Dupixent is being developed jointly by Regeneron and Sanofi as part of a global collaboration agreement. In October 2018, Dupixent was approved in the U.S. as an add-on maintenance therapy in patients with moderate-to-severe asthma aged 12 years and older with an eosinophilic phenotype or with oral corticosteroid-dependent asthma. Dupixent is not used to treat sudden breathing problems. Dupixent is currently under regulatory review for specific types of asthma in Japan.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Amazon.com, Inc. can be held liable for damages caused by defective goods sold on its Marketplace including third parties, according to a ruling by a California appeals court. The California Fourth District Court of Appeals was pronouncing the ruling in a case where a defective replacement laptop battery caught fire and inflicted a woman with third-degree burns. Facebook has launched "Voting Information Center" on Facebook and Instagram platforms, with a view to boosting the number of Americans vote in the upcoming U.S. presidential election in November. The social media giant's latest initiative is expected to help 4 million voters register this year, and help them navigate a 'confusing election process'. Epic Games Inc., the developer of popular game Fortnite, has filed lawsuits against both Apple Inc. and Google after they removed the game from their app stores. The development reflects disputes related to app store fee the tech giants take from each purchase. Epic Games, which has been against the 30 percent revenue cut the two tech giants take from paid apps, added a direct payment option.
Follow RTT