Regeneron moves closer to European approval of drug for asthma

Tarrytown-based Regeneron Pharmaceuticals has announced that a drug it is developing jointly with the international pharmaceutical company Sanofi has received a positive opinion from the European Medicines Agency”™s Committee for Medicinal Products for Human Use (CHMP) regarding the drug”™s use in treating asthma. The drug is Dupixent.

In the U.S., it is indicated for use by prescription to treat moderate-to-severe atopic dermatitis, also known as eczema. It also is indicated for use with other asthma medications for the maintenance treatment of moderate-to-severe asthma in people 12 years and older whose asthma is not controlled with their current medications.

According to the Mayo Clinic, atopic dermatitis is a chronic condition which may be accompanied by asthma or hay fever. It is characterized by a red, itchy rash.

In the European Union, Dupixent is currently indicated for use in adults with moderate-to-severe atopic dermatitis who are candidates for systemic therapy.

The recommendation by CHMP appears to move the drug closer to receiving an indication for use in the European Union for the treatment of asthma. Regeneron said that a decision is expected in a few months.

Regeneron reported that CHMP based its positive opinion on data from clinical trials which involved 2,888 adults and adolescents.  

Dupixent is a human monoclonal antibody. Monoclonal antibodies are developed in laboratories and can be designed to target specific factors. Dupixent, for example, inhibits the functioning of two key proteins involved in inflammation, which is an underlying factor in some allergic diseases such as asthma.