Sanofi to Proceed With Regulatory Submissions for Amlitelimab in Atopic Dermatitis

MT Newswires Live01-23 18:15

Sanofi (SNY) said Friday it will proceed with global regulatory submissions for amlitelimab for the treatment of atopic dermatitis, an inflammatory skin condition.

Two global phase 3 studies of amlitelimab delivered results that support its potential as a treatment for moderate-to-severe atopic dermatitis in patients aged at least 12 years.

The SHORE study met all primary and key secondary endpoints. The company said that while the COAST 2 study showed "statistically significant efficacy" on the primary endpoint assessed for US and US reference countries, it did not show statistical significance in the co-primary endpoints for the European Union and EU reference countries.

Sanofi said amlitelimab was well-tolerated in both studies, with safety profile consistent with previous data.

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