(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.
(Reporting by Siddhi Mahatole in Bengaluru; Editing by Sahal Muhammed)
Comments