Submit diagnosis criteria for lower respiratory infection and earlier study data: CDSCO Panel Tells Pfizer on Sisunatovir capsule

New Delhi: Reviewing the Phase 1b clinical study protocol for Sisunatovir 50 mg capsules, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the drug major Pfizer to submit the diagnosis criteria for lower respiratory infection with either reference or guidelines and earlier study data of phase-I conducted in pediatrics, including infants.

Furthermore, the expert panel suggested that pharmacokinetic parameters should be included in the protocol.

This came after the drug major Pfizer presented phase 1b clinical study protocol no. C5241009 Amendment 4 dated 11.03.2024.

Sisunatovir is an orally available, small-molecule inhibitor of the 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.

At the recent SEC meeting for pulmonary held on August 6, 2024, the expert panel reviewed phase 1b clinical study protocol no. C5241009 Amendment 4 dated 11.03.2024.

After detailed deliberation, the committee opined that the firm shall submit the following for further review by the committee in the presence of one pediatric pulmonary expert:

(i) The diagnosis criteria for lower respiratory infection with either reference or guideline.

(ii) Earlier study data of phase-I conducted in pediatrics, including infants.

(iii) Pharmacokinetic parameters should be included in the protocol.

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