Sanofi and Regeneron’s projected blockbuster gains EU approval

Sanofi and Regeneron have big hopes for their treatment Dupixent, and it has taken an important step towards reaching the blockbuster sales pinned to it with an approval in the EU. The treatment has been approved for the treatment of moderate-to-severe atopic dermatitis.

The approval comes after a recommendation from the EMA’s CHMP for approval back in July, and follows on from the FDA’s approval back in March. The two companies have continued to release a raft of data on the drug, in attempt to boost sales over rivals in the inflammatory disease area.

Earlier this month, the companies released data at the European Academy of Dermatology and Venereology Congress to reveal that the drug improved clearance of eczema by up to 80% in patients receiving the drug alongside corticosteroids, compared with only 30% in patients receiving the steroids alongside placebo.

The patients that participated in the trial were intolerant or did not respond to cyclosporine A, a treatment currently used across Europe and Japan for atopic dermatitis.

"Dupixent represents the culmination of decades of our scientific research into the biology of allergic diseases such as moderate-to-severe atopic dermatitis," said George D. Yancopoulos, President, and Chief Scientific Officer, Regeneron. "We continue to evaluate the potential of dupilumab in the treatment of atopic dermatitis in children and adolescents as well as other allergic inflammatory diseases driven by the IL-4/IL-13 pathway."

One other such inflammatory disease that the companies are taking a close look at for Dupixent is asthma; the companies released data on its efficacy in the area early in the month but analysts were not blown away. Though the drug showed an improvement in severe asthma attacks by 46% in the overall population, this was deemed not too dissimilar to rivals in the area.

The problem it may have is to differentiate itself from competitors, yet analysts still predict that the drug may reap peak annual sales of $5.53 billion by 2023.