Dr. Reddy's To Submit Final Clinical Trial Data From Russia For Sputnik Light Approval
After the Indian drug regulator denied permission to conduct phase III study of single-dose Sputnik Light locally, Dr. Reddy's Laboratories Ltd. will submit results of the final clinical trial underway in Russia.
Dr. Reddy's had presented the interim safety and efficacy data from the phase I and II trials in Russia and a proposal to conduct the third phase in India, the company said in an exchange filing on Friday. The regulator's Subject Expert Committee said the safety, immunogenicity and efficacy results from the final trail in Russia would be needed to consider "marketing authorisation" of Sputnik Light in India.
The regulator on June 30 denied approval for conducting the final trial in India. This single-dose version of the Sputnik V, already approved for emergency use in India, was expected to speed up the pace of inoculation amid the looming threat of a third wave of Covid-19.
Since Sputnik Light is nothing but the first dose of Sputnik V, the committee said that trial has already been conducted in India, according to the filing, and there seems to be inadequate data and justification in conducting a separate similar study.