Dr Reddy's gears up for weight loss drug study
Dr Reddy's Laboratories has got a go-head from the Subject Expert Committee (SEC) under India's drug regulatory authority to conduct a bioequivalence study required to establish the safety and efficacy of the blockbuster weight loss drug Semaglutide on the Indian population.
Dr Reddy's had approached the SEC in April with a proposal for manufacture and marketing of synthetically developed Semaglutide injection 2mg/1.5ml (1.34mg/ml) and Semaglutide injection 4mg/3ml (1.34mg/ml). The company had also sought a waiver of BE study and Phase III clinical trial.
However, the SEC recommended the company conduct a bioequivalence study and asked it to submit the protocol for the same for further review.
At a SEC meet on September 29, «the committee recommended for grant of permission to conduct bioequivalence study as per protocol presented by the firm,» as per the minutes of the meeting.
The committee said the Phase-III clinical trial waiver can be considered based on the review of the bioequivalence study report by the committee, it further said.
ET has seen the minutes of the meeting.
If all goes as per plan, the injection could be launched in a year, an industry insider said on the condition of anonymity.
The drugs — Wegovy and Ozempic — that share the same ingredient, Semaglutide, are all the rage ever since Elon Musk tweeted about it.
