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.