Sanofi announces FDA accelerated approval for Tzield
The authorization covers children aged eight to 17 recently diagnosed with stage 3 type 1 diabetes and is supported by PROTECT phase 3 data and over 900 treated patients.
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In short: Sanofi appointed Belén Garijo as CEO, expanded its AI hub in Toronto, and advanced its pipeline despite the discontinuation of several late-stage trials.
The authorization covers children aged eight to 17 recently diagnosed with stage 3 type 1 diabetes and is supported by PROTECT phase 3 data and over 900 treated patients.
The study was halted after an interim analysis showed insufficient efficacy; no safety concerns were noted.
It is the first anticancer treatment to be administered via an on-body injector, offering flexibility for home or outpatient settings.
If approved, it would be the first treatment for neurological manifestations of type 3 Gaucher disease.
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