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
Alibaba is upgrading its intellectual property system using blockchain technology, according to local news outlet Sohu. Alibaba Platform Management expects this to benefit mainly small and medium-sized enterprises, brands and entrepreneurs. The technology will be fully implemented in September, and thereafter, the company intends to expand it to the field of digital copyright protection. Electronics retailer Best Buy Co., Inc. (BBY) reported Thursday a 27 percent increase in profit for the first quarter from last year, which was impacted by restructuring charges, and higher revenues. Both adjusted earnings per share and revenues for the quarter topped analysts' estimates. The company also provides guidance for the second quarter and reiterated its outlook for the full-year 2020. While reporting financial results for the second quarter on Thursday, Hormel Foods Corp. (HRL) lowered its earnings and net sales guidance for the full-year 2019. For fiscal 2019, the company now projects earnings in a range of $1.71 to $1.85 per share, and net sales between $9.70 billion and $10.20...
Follow RTT