Sanofi's Tzield: FDA Fast-Tracks Review for Type 1 Diabetes

Sanofi announced that its treatment, Tzield, has had its Biologics License Application accepted for expedited review by the FDA. This drug aims to slow the progression of stage 3 type 1 diabetes in adults and children eight years of age and older who have been recently diagnosed. Tzield could become the first disease-modifying therapy in this area.

Tzield's acceptance under the Commissioner's National Priority Voucher underscores its potential in medicine, addressing unmet medical needs. The FDA could reduce the typical review time from 10 to 12 months to just one to two months. This would allow Sanofi to bring this treatment to patients more quickly.

The results of the PROTECT study, supporting this application, show significant preservation of beta cell function compared to placebo. Tzield is already approved in several countries to delay the onset of advanced type 1 diabetes.