Modify Clinical study protocol of Iptacopan study in aHUS: CDSCO Panel Tell Novartis

Iptacopan is a factor B inhibitor used to treat paroxysmal nocturnal hemoglobinuria. Iptacopan is a small-molecule factor B inhibitor previously investigated as a potential treatment for the rare blood disease paroxysmal nocturnal hemoglobinuria (PNH) by inhibiting the complement factor B

At the recent SEC meeting for Renal held on 20th February 2024, the expert panel reviewed the proposal presented by the drug major Novartis to conduct Phase IIIb clinical trial protocol No. CLNP023F12001B.

After detailed deliberation, the committee opined that the following information is to be submitted for further review by the committee.

a. Serial number 3 of inclusion criteria should be revised for more objectivity, defining objective criteria based on which the investigator will assess that the participant has benefitted.

b. In the section describing the duration for which the study drug will be provided to participants, conditions number 2 and 3 should be defined more objectively.

“(Participants no longer derive benefit from Iptacopan” and the benefit-risk profile of the product is no longer positive)”.

c. In exclusion criteria, women of childbearing potential should be redefined.

d. Explanation for spontaneous abortion to be provided.

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