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Sanofi: cemiplimab designated 'breakthrough therapy' by FDA.

(CercleFinance.com) - Sanofi and Regeneron have announced that the FDA has designated cemiplimab as a breakthrough therapy for the treatment of metastatic cutaneous epidermoid carcinoma (CEC) and non-resectable locally advanced CEC in adults.


Cemiplimab is being developed by Sanofi and Regeneron as part of a global collaboration agreement. They intend to apply for an organic product license at the FDA in the first quarter of 2018 when data and results become available.

The purpose of the breakthrough therapy discovery is to accelerate the development and regulatory steps of new experimental drugs for the treatment of certain diseases that are considered to be serious or life-threatening.


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