Johnson and Johnson Rilematovir gets CDSCO panel okay for phase 3 trial

However, permission has been granted based on a condition that the firm should submit the safety and efficacy interim trial data in infants and children (along with the IDMC report) to the CDSCO/Committee for review and, after review of the same, the study in the neonate population should be initiated.

The recommendation came following a presentation by the firm on proposed phase III study protocol no. 53718678RSV3001 dated17Aug2020 with data and justification.

The Respiratory syncytial virus (RSV) is considered the most important cause of acute lower respiratory tract infection (LRTI) in infants and young children.

Rilematovir (RMV) is a specific small molecule that blocks entry of the RSV by inhibiting fusion of the viral envelope with the host cell membrane. It is developed for the treatment of RSV A and B infections.

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Earlier, at the 98th SEC meeting for Antimicrobial & Antivirals held on 23.06.2021 & 24.06.2021, drug maker J & J presented the proposal for a clinical trial to be conducted on infants and children (≥28 days to ≤5 years of age) and subsequently on neonates (< 28 days of age).

In line with the presented proposal, the committee noted that the safety profile of the study drug from preclinical and clinical studies justifies the conduct of the trial and, after detailed deliberation, recommended the firm to provide the safety data generated so far with the IMP (Rilematovir) in support of the Clinical Trial in the proposed subjects and the proposal should be deliberated in the presence of a pediatrician.

In continuation with the above, at the latest SEC meeting for Antimicrobial & Antivirals held on 27.07.2021, the firm presented the proposed phase III study protocol no. 53718678RSV3001 dated 17Aug 2020 with data and justification.

Responding to this, after detailed deliberation, the Committee recommended the grant of permission to conduct the study with the condition that the firm should submit the safety and efficacy interim trial data in infants and children (along with the IDMC report) to the CDSCO/Committee for review and, after review of the same, the study in the neonate population should be initiated.

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