The French pharmaceutical giant Sanofi and its American partner Regeneron announced on Tuesday that Dupixent (dupilumab), the first biomedicant indicated for the treatment of severe eczema, has been approved in the United States, in which Sanofi places a lot of hope.
A wholesale price of 37.000 dollars per patient per year has been set for this treatment, which had been labeled "therapeutic breakthrough" in this indication by the US Drug Administration (FDA) in 2014. to benefit from a priority review.
"The real costs for patients, payers and health systems should be lower because the wholesale price does not take into account potential rebates or rebates, or patient support programs," says Sanofi. a statement.
About 300.000 adults in the US suffer from moderate atopic dermatitis severe uncontrolled, according to the group.
Sanofi has also filed late 2016 an application for authorization of Dupixent in the European Union for the same indication.
The group is betting on a "late 2017 or early 2018" approval in the EU, AFP chief executive Olivier Brandicourt told AFP on Tuesday, saying the safety profile of the treatment is "quite reassuring".
According to a consensus of analysts, this drug, which is to be taken over time with two injections per month, could become a blockbuster from 2019, a drug exceeding the symbolic threshold of one billion euros in annual sales. .
It is a human monoclonal antibody designed to inhibit the "overactive signaling" of two key proteins, IL-4 and IL-13, "which are in all likelihood the major factors of the underlying permanent inflammation characteristic of atopic dermatics, "the statement said.
Dupilumab is also studied by Sanofi in the treatment of other inflammatory diseases "presumably modulated" by the same proteinsIL-4 and IL-13, especially severe asthma.
The results of a Phase III clinical trial in this indication are expected later this year.
The goal is to "submit the indication of severe asthma in the fourth quarter to the FDA" according to Mr. Brandicourt.
The Dupixent commercial success could still be compromised in case of trial by US biotech Amgen who could claim infringement of certain patents.
Last week, Sanofi and Regeneron seized American justice, in a preventive way, to try to prove in advance their legitimacy over Dupixent in relation to Amgen's patents.
The two allies are already stuck in a dispute of this kind in the United States for their anti-cholesterol Praluent, direct competitor of Repatha d'Amgen.