A subject expert committee (SEC) has turned down Dr. Reddy’s Laboratories proposal for change in regulatory approval status for Remdesivir injection from restricted emergency use to full marketing authorisation. “After detailed deliberation, the committee did not recommend for grant of full marketing authorisation and opined that approval for restricted emergency use of the drug should continue,” the Central Drugs Standard Control Organisation said on the recommendations of the SEC meeting held on October 29.
The DCGI had approved the antiviral drug for restricted emergency use in the treatment of COVID-19 patients hospitalised with severe symptoms. Dr. Reddy’s had launched a generic version of Remdesivir, under Redyx brand, in September following a licensing agreement with Gilead Sciences.
In its proposal to the SEC, which examines COVID-19 related proposal under accelerated approval process, Dr.Reddy’s had presented clinical data and sought a change in the regulatory approval status of Remdesivir lyophilised powder for Injection 100mg to full marketing authorisation.
Another proposal rejected
Also, the SEC turned down another proposal of Dr. Reddy’s seeking approval for restricted emergency use of 2-Deoxy-D-Glucose oral powder, for COVID-19 patients. The Committee, however, recommended for grant of permission to conduct Phase III clinical trial of the drug, subject to certain conditions.
According to CDSCO, the firm had presented the proposal for approval of the drug for restricted emergency use and Phase III Clinical Trial protocol. This followed the SEC meeting on October 13 recommending that firm should submit phase III clinical trial protocol with adequate sample size and clearly defined inclusion exclusion criteria, primary and secondary end points.
In its latest meeting, the committee reiterated its earlier recommendation in respect of their proposal and did not recommend for approval of the drug for restricted emergency use as no additional data was presented.
On Phase III Clinical Trial, committee recommended for grant of permission to conduct Phase III Clinical Trial subject to certain conditions, including the firm appointing a medical monitor for co-ordination and monitoring the trial at all the sites.
