Type 1 diabetes antibody drug teplizumab won the U.S. FDA advisory board...

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Recently, Provention Bio's innovative diabetes preventive therapy teplizumab has received good news in the US supervision.

Specifically, the FDA Endocrine and Metabolic Drug Advisory Committee (EMDAC) voted with 10 votes in favor and 7 votes against, supporting the benefits of teplizumab, which is an anti-CD3 monoclonal antibody used for prevention or delay in high-risk groups.

In clinical trials supporting the drug NDA, a 2-week course of teplizumab treatment can delay the onset of type 1 diabetes by an average of 2 years.

However, members of the expert panel were concerned that the scale of this clinical trial was too small (teplizumab only treated 44 people and did not meet the enrollment goal) and that there was no follow-up after the patient was diagnosed with diabetes.

This clinical trial conducted teplizumab testing on relatives of patients with type 1 diabetes who are 8 years of age and older, have 2 or more types of type 1 diabetes autoantibodies and abnormal glucose metabolism (abnormal blood sugar), but have not yet developed diabetes symptom.

Several panelists pointed out that compared with 32 subjects who received placebo, 44 ​​subjects who received teplizumab had a higher rate of serious side effects (16% vs 3%), and there were 3 subjects in the teplizumab group The subject died, but not in the placebo group.

David Nathan, MD, director of the Diabetes Center and Clinical Research Center at Massachusetts General Hospital, said these results "point in a potentially dangerous direction.

Michael Blaha, Professor of Cardiology and Epidemiology at the Johns Hopkins Ciccarone Cardiology Prevention Center, only supports the approval of teplizumab for very narrow populations, "I will only support the approval of this drug for the exact indications in its registered trials It is recommended to carry out another confirmatory trial to include patients who do not meet the criteria.

However, some experts expressed different opinions.

However, Connie Newman, an associate professor of medicine at New York University's Langon School of Medicine, expressed concern about the efficacy of teplizumab in a large population, because more than 97% of the trial participants were white.

In addition, other experts have also conducted extensive discussions on the effectiveness and safety of teplizumab, whether another confirmatory trial and post-marketing research are needed, and expressed different opinions.

It should be pointed out that in terms of drug approval, the FDA is not bound by the recommendations of its advisory committee, but the agency usually follows these recommendations and is expected to make a final review decision on teplizumab before July 2.

Reference source: Provention Bio brought back down to earth as FDA panel narrowly backs diabetes prevention drug