Sanofi/Regeneron plan US filing of potential eczema blockbuster
Sanofi and Regeneron have said they are preparing a US filing for their hotly-anticipated dupilumab in serious eczema later this year following strong phase 3 results.
The companies said today that they plan to file the antibody that blocks interleukin-4 and interleukin-13 signalling pathway in Q3.
Analysts have predicted that dupilumab could become a blockbuster for the companies, particularly if it is approved in a second asthma indication.
Dupilumab has already been granted Breakthrough Therapy status in the US in serious eczema, allowing faster development.
Sanofi’s president of global R&D, Elias Zerhouni, said: “In the US, where dupilumab in atopic dermatitis has been granted Breakthrough Therapy designation by the US FDA, we plan to submit a regulatory application in the third quarter of this year and will work to bring this innovative therapy to patients as quickly as possible.”
They said the drug is the first systemic therapy to show positive phase 3 results in patients with moderate-to-severe atopic dermatitis.
The companies announced results from the SOLO 1 and SOLO 2 trials, involving a total of 1,379 adults with moderate to severe disease.
Sanofi and Regeneron said the drug met the primary endpoint required by the US regulator, based on clearance of skin lesions.
It also met both endpoints required by the European Medicines Agency – the skin lesion score and a reduction in area and severity of eczema. The latter was a secondary endpoint in the US.
For the 16-week treatment period, the overall rate of adverse events (65-73% dupilumab and 65-72% placebo) was comparable between the dupilumab groups and the placebo groups.
Adverse events noted to have a higher rate with dupilumab were injection site reactions and conjunctivitis.
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