CDSCO Panel Approves Pfizer's Protocol Amendment Proposal for antimicrobial drug Sisunatovir study
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the protocol amendment proposal presented by the drug major Pfizer for the antimicrobial drug Sisunatovir Tablet.
This came after the firm presented protocol amendment 1 dated 30 April 2024 protocol No. C5241007.
Sisunatovir is studied for the possible treatment of Respiratory Syncytial Virus (RSV). RSV is a virus that causes lung infections with cold-like symptoms, but it can cause severe illness in some people.
RSV infects the target cell via the attachment of G protein, followed by fusion of the virus and host cell membrane mediated by F protein, resulting in release of the genomic RNA into the cytoplasm.
Sisunatovir is an orally available, small molecule inhibitor of human respiratory syncytial virus (RSV) fusion protein (F protein), with potential antiviral activity. Upon oral administration, sisunatovir specifically targets and binds to RSV-F protein on the viral surface, which inhibits RSV-F protein-mediated fusion with the host cell membrane and prevents viral entry. This blocks RSV replication, reduces viral load, and decreases the severity of the disease. RSV-F protein, a viral surface glycoprotein, plays a key role in RSV fusion with and entry into target cells.
Earlier, the Medical Dialogues Team had reported that the drug major Pfizer had got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to conduct the Phase 2/3 clinical trial of Sisunatovir IR tablets 100 mg.
At the recent SEC meeting for antimicrobials and antivirals held on 22nd August 2024, the expert panel reviewed Protocol Amendment 1, dated 30 April 2024, Protocol No. C5241007.
After detailed deliberation, the committee recommended the approval of the protocol amendment as presented by the firm.
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