(Reuters) -The European Medicines Agency’s committee has recommended approval of French drugmaker Sanofi’s first-of-its-kind drug that delays onset of the insulin-dependent stage 3 of type 1 diabetes, it said on Friday.
Teizeild, chemically known as teplizumab, was already approved in the U.S. in November 2022 for patients with stage 2 of the disease that typically show no symptoms.
In March 2023, Sanofi had acquired U.S-based biotech Provention Bio for $2.9 billion, giving the French drugmaker full ownership of the teizeild.
The drug slows the immune system’s attack on insulin-producing cells and is given as a daily infusion for 14 days.
The EMA’s recommendation follows a placebo-controlled trial with 76 patients, aged 8 years and above, which showed teplizumab doubled the median time

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