CDSCO Panel Withholds Nod for Syngene's Pegfilgrastim Trial, Seeks Additional Data
New Delhi: The Subject Expert Committee under the Central Drugs Standard Control Organisation (CDSCO) has directed Syngene International Limited to submit additional data before it proceeds further with evaluating the firm's proposal to conduct a Phase I clinical trial comparing Pegfilgrastim administered through an On-Body Injector (OBI) kit and a prefilled syringe (PFS).
The firm had presented its application for a Phase I study titled: “A Randomized, Open-label, Single-dose, Three-period, Two-treatment, Three-sequence, Partial Replicate Crossover Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Fulphila OBI kit and Fulphila PFS (pegfilgrastim) for manual use in Normal Healthy Male Volunteers.” This was submitted under protocol number SYNCD-052-24/BIO-PEGFIL-102 Version 2.0 dated 5 June 2025.
Pegfilgrastim is a long-acting form of recombinant human granulocyte colony-stimulating factor (G-CSF), used to prevent febrile neutropenia in cancer patients undergoing chemotherapy. It reduces the duration of neutropenia and the risk of infection by stimulating the bone marrow to increase neutrophil production. The PFS and OBI formats are designed to improve delivery efficiency and patient convenience.
During the SEC’s 23rd Oncology meeting held on 17 July 2025 at CDSCO headquarters, the expert panel reviewed the proposal and made several key observations.
The committee noted that the proposed Pegfilgrastim in prefilled syringes (PFS) is already approved in more than 45 countries, including the United States, European Union, Canada, Australia, and Switzerland. Furthermore, the panel acknowledged that the current submission represents a line extension approval in both the EU and the USA.
However, before approving the study, the committee has asked the firm to submit additional data, specifically:
In-use stability data of the drug when used with the OBI kit
Data on the functionality and performance evaluation of the OBI device
“Accordingly, the firm shall submit the above information for further evaluation by the SEC.”
