Revise clinical trial protocol for Remdesivir powder for inhalation: CDSCO panel tells Lupin
New Delhi: In response to the drug maker Lupin's proposal to conduct a PhaseII/III Clinical Trial protocol for Remdesivir Powder for Inhalation, the Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organization (CDSCO) has opined that the firm should conduct a Phase-II Clinical Trial of Remdesivir powder for inhalation and, accordingly, the firm should revise and submit the clinical trial protocol to the committee for further consideration.
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.
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