Revise clinical trial protocol for Remdesivir powder for inhalation: CDSCO panel tells Lupin

The recommendation came after the firm presented the proposal of PhaseII/III Clinical Trial protocol for Remdesivir Powder for inhalation.

Remdesivir is an inhibitor of the viral RNA-dependent RNA polymerase. It possesses an in vitro inhibitory activity against SARS-CoV-1 and the Middle East respiratory syndrome (MERS-CoV). It was identified early as a promising therapeutic candidate for Covid-19 because of its ability to inhibit SARS-CoV-2 in vitro.

Remdesivir is approved in India for restricted emergency use for the treatment of suspected or laboratory confirmed COVID-19 in adults and children hospitalized with severe disease.

The SEC committee in its 169th meeting held on 29.07.2021 at CDSCO, HQ New Delhi, reviewed the proposal regarding Remdesivir powder for inhalation.

Responding to the proposal presented by the firm, after detailed deliberation, the SEC committee recommended that the firm should conduct a Phase-II clinical trial.

Accordingly, the firm should revise the CT protocol with respect to study design, sample size, inclusion and exclusion criteria, efficacy endpoint, SOC standardization, etc. and submit the same for further consideration by the committee.