Boehringer Ingelheim Told to File Separate Phase IV Trial Plan for Empagliflozin

New Delhi: The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) has directed Boehringer Ingelheim India to submit a separate Phase IV clinical trial protocol for Empagliflozin Tablets 10 mg/25mg within one month, for compliance with the condition of import and marketing permission dated 18/01/2024.

This came after the firm presented the summary of the ongoing Phase III Global Clinical Trial Protocol (EASi-KIDNEY) vide Protocol No. 1378-0006 and requested to consider the data generated from Indian patients with Empagliflozin Tablets 10 mg as the compliance of Phase-IV Clinical Trial condition of import and marketing permission dated 18.01.2024 issued for Empagliflozin Tablets 10 mg and 25 mg for CKD indication.

Further, the firm informed that Empa