Sanofi: FDA Accepts SBLA For Tzield For Expedited Review

(RTTNews) - Sanofi (SNY) said the FDA has accepted for expedited review the supplemental biologics license application for Tzield to delay the progression of stage 3 type 1 diabetes in adults and pediatric patients eight years of age and older recently diagnosed with stage 3 T1D. The sBLA is supported by the results from the PROTECT phase 3 study.

The company noted that FDA nominated Tzield for the Commissioner's National Priority Voucher pilot program based on its potential to address a large unmet medical need. The CNPV program aims to shorten the review process to 1-2 months.

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