French pharmaceutical firm Sanofi said on Friday that its flagship drug Dupixent has been recommended for approval by the European Union’s drug watchdog for treating an allergic condition of the esophagus.
The European Medicines Agency’s CHMP committee “has adopted a positive opinion, recommending the approval of Dupixent” in the bloc for people aged 12 and older with eosinophilic esophagitis, the pharmaceutical giant said in a statement.
It is now up to the European Commission to decide whether to approve the drug, which is normally done in the weeks following CHMP’s recommendation.
Sanofi said that if the drug does get the green light, it will be “the first and only targeted medicine specifically indicated for people” 12 and over with the condition in the EU.
Eosinophilic esophagitis is a chronic immune system disease that causes inflammation of the esophagus. Symptoms include trouble swallowing, chest and abdominal pain as well as vomiting.
Around 50,000 adults and adolescents have the condition in the EU, Sanofi said.
Earlier this year, Dupixent was authorised in the United States for treating eosinophilic esophagitis.
The drug has already been approved in the EU for other illnesses including asthma and eczema.
In October, Sanofi revised its 2022 outlook upwards on the back of strong sales of Dupixent, which represents around a fifth of the firm’s turnover.
Despite the new recommendation, Sanofi stocks slid some 1.5 percent Friday on the Paris stock exchange, which itself dropped by around that amount.
(AFP)
