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Sanofi's type 1 diabetes drug recommended for EU approval
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Sanofi's type 1 diabetes drug recommended for EU approval
Nov 14, 2025 5:42 AM

Nov 14 (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 to stage 3 onset to 50 months

versus 25 months with placebo.

Fewer patients progressed to stage 3 on teplizumab compared

with placebo.

The recommendations made by the EMA's Committee for

Medicinal Products for Human Use will now be reviewed by the

European Commission for marketing authorization in the European

Union.

Type 1 diabetes, previously known as juvenile diabetes, is a

disease in which the immune system attacks and destroys the

insulin-producing beta cells in the pancreas, leaving sufferers

reliant on regular insulin injections.

It affects about 2.2 million people in the EU and currently

has no authorised treatment to slow its progression, the

regulator said.

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