CDSCO panel declares Pfizer's antifungal drug Isavuconazole safe, well tolerated
New Delhi: Deliberating the post-marketing surveillance (PMS) study report of the Isavuconazole Capsule 100mg & 200mg powder for concentrate for solution for infusion presented by the drug major Pfizer, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has stated that Isavuconazole was safe and well-tolerated.
Isavuconazole is a triazole antifungal with a broad spectrum of activity and a good safety profile. Isavucoanzole exhibits antifungal activity against most strains of Aspergillus flavus, Aspergillus fumigatus, Aspergillus niger, and Mucorales such as Rhizopus oryzae and Mucormycetes species in vivo and in vitro
Isavuconazole acts by disrupting the biosynthesis of ergosterol, which is a key component of the fungal cell membranes. It inhibits cytochrome P-450-dependent enzyme lanosterol 14-alpha-demethylase that mediates the conversion of lanosterol to ergosterol.
The committee noted that the firm was granted import and marketing permission for Isavuconazole Capsule 100mg & 200mg powder for concentrate for solution for infusion on 14.02.2020 and 11.03.2020 respectively subject to the condition that "Active PMS study should be conducted on at least 50 patients of confirmed cases of Invasive Aspergillosis and 20 patients of confirmed cases of Invasive Mucormycosis".
Therefore, the firm submitted the PMS study protocol for the Isavuconazole Capsule 100mg & 200mg powder for concentrate for solution for infusion at the SEC meeting for Antimicrobial & Antiviral held on the 7th of August 2020.
In continuation with the above, the permission to conduct the PMS study was issued by CDSCO on 24.08.2020.
Furthermore, in line with the PMS study, at the recent SEC meeting for antimicrobial and antiviral held on 31 January 2023, the firm presented the PMS study report before the committee.
After detailed deliberation, the committee noted that the total number of deaths during the study was 41 (58.6%), which were majorly COVID-19 related.
In addition, the committee added, "No treatment related adverse drug reactions (ADR), serious ADR or ADRs leading to treatment discontinuation were reported."
Lastly, the committee concluded that isavuconazole was safe and well tolerated in the study.
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