Update (01/10/2017): The European Commission has granted marketing authorization to Dupixent (dupilumab) for the treatment of atopic dermatitis in adults who are candidates for systemic therapy.
Originally published on 18/09/2017
Sanofi and Regeneron have results supporting the European approval of Dupixent (dupilumab), currently the center of a heated pricing discussion in the US.
Sanofi and Regeneron presented positive results for Dupixent (dupilumab) in atopic dermatitis at the European Academy of Dermatology and Venereology (EADV) Congress this Saturday. The Phase III CAFÉ study, which recruited 325 patients in Europe, revealed that the drug could improve the clearance of eczema by up to 80% in patients receiving the antibody in combination with topical corticosteroids (TCS) as compared to 30% clearance in patients receiving TCS and placebo. The drug also improved additional symptoms of itching, anxiety and depression.
These results are consistent with three previous trials in a total of 2119 patients that supported the launch of Dupixent in the US in March. In the new trial, the patients that participated did not respond or were intolerant to cyclosporine A, a common treatment for atopic dermatitis in Europe and Japan, but not approved in the US.
Sanofi and Regeneron are now awaiting a decision by the European Commission on the approval of Dupixent in Europe, which seems likely after the drug received a positive opinion from the CHMP in late July. The team expects to launch the drug in Germany, its first EU market, by the end of the year.
Dupixent has been at the center of a pricing discussion in the US after its price was revealed to be set at $37,000 (€31,000) per year. The drug has been predicted to become a blockbuster and bring over $5Bn (€4.2Bn) a year during peak sales, but some analysts are skeptic after similar predictions for cholesterol drugs Praluent and Repatha, as well as Novartis’ Entresto for heart failure, failed to meet the multi-billion sales expectations.
“A few years ago, just winning approval meant getting wide access,” stated RBC Capital Markets analyst Simos Simeonidis. “That’s definitely not the case anymore.” This effect has been largely blamed on doctors and insurers rejecting it for their exorbitant price.
However, pharmacy benefit manager Express Scripts and the Institute for Clinical and Economic Review have qualified the price of the drug as cost-effective despite being expensive, given the lack of alternatives for patients with atopic dermatitis. Dupixent already made €26M in sales in the second quarter of 2017 after its launch in March, which lines up with optimistic predictions by Wall Street analysts.
It remains to be seen what the pricing will be like in Europe, and though it will vary between countries, it’s likely it will be lower than in the US given the tighter control over pricing that governments have over here
Images via Tero Vesalainen, Roman Stetsyk /Shutterstock