Log in

Commercial green light to the US for treatment of Sanofi against severe eczema

The French pharmaceutical giant Sanofi and its US partner Regeneron announced Tuesday the approval of the US Dupixent (dupilumab), a first biomedicine indicated for the treatment of severe eczema in which Sanofi has high hopes.

A wholesale price 37.000 dollars per year per patient was set for this treatment, which was obtained by 2014 the designation of "therapeutic breakthrough" in this indication by the US Drug Agency (FDA), which allowed him to receive a priority review.

"The actual costs for patients, payers and health systems should be lower because the wholesale price does not take into account any discounts or rebates or aid programs offered to patients," Sanofi says in a statement.

About 300.000 adults in the US suffer from moderate atopic dermatitis severe uncontrolled, according to the group.

Sanofi also filed late 2016 a Dupixent authorization application in the EU in this indication.

The group put on approval "2017 2018 beginning or end" in the EU, said Tuesday in AFP's CEO Olivier Brandicourt, saying "quite reassuring" the safety profile of the treatment.

According to a consensus of analysts, this drug, to be taken in the length at two injections per month could soon become 2019 a "blockbuster" drug exceeding the symbolic threshold of one billion euros in annual sales .

This is a human monoclonal antibody designed to inhibit "hyperactive signaling" of two key proteins, IL-IL-4 and 13, "which are in all likelihood the main factors of the standing underlying inflammation characteristic of atopic dermatique, "the statement said.

Dupilumab is also studied by Sanofi for the treatment of other inflammatory diseases "likely modulated" by the same proteinsIL-4 and IL-13, particularly severe asthma.

The results of a clinical phase III trial for this indication is 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.

Sanofi and Regeneron have also seized last week American justice, preventively, to try to prove their legitimacy in advance on Dupixent compared to Amgen patents.

The two allies are already mired in a dispute of this kind in the United States for their cholesterol-lowering Praluent, direct competitor of Amgen Repatha.

a3p-100pxhaut logo


Commit to share
Transmit and progress together
Promoting innovation

The A3P Association is a major player in the pharmaceutical and biotechnology industry.
Created in 1986, it contributes to the good development of the production of medicines and clean and sterile equipment, it runs a network of professionals 21 000, manufacturers and suppliers, as part of International Congress and technical days.

It now has over 1700 members who share their technical experience, scientific and regulatory.

More info on video (Versiongb - drapeauitalie )

  group    administrators A3P
& Project Managers

letter   newsletter A3P