Strides Pharma gets FDA greenlight to market HIV treatment

Bangalore, India-based Strides Pharma Global has announced that it has received approval from the US Food and Drug Administration (FDA) to market three generic drugs intended to treat HIV.

The three tablets, efavirenz (600mg), emtricitabine (200mg), and tenofovir disproxil fumurate (300mg), known collectively as EET, have been approved as generic alternatives to Gilead Sciences’ Atripla.

The greenlight for the bioequivalent marks the 15th product developed by the firm, within the same therapeutic category, to see success through the US Government’s Emergency Plan for AIDS Relief’s (PEPFAR) pathway.

A spokesperson for Strides Pharma Global said: “The PEPFAR approval for Strides qualifies the company to participate in global donor-funded programs that procure this lifesaving medicine and it is supplied in around 10 countries.

“As of full year 2022, donor procurement for EET Tablets is estimated at a value of around 15 million USD. This product further strengthens the available offerings in HIV treatment from Strides.”

The company has said that the drug has a market opportunity in the US of $7.5m. As per Global Data’s Pharmaceutical intelligence Centre the originator drug—Gilead’s Atripla—earned $121 million in revenues 2021, which was down from the previous year’s sales of $307 million.

Global Data is the parent company of Pharmaceutical Technology.

The drug is set to be manufactured at the company’s facility in Bengaluru. As a result of the announcement Shares of Strides Pharma Science jumped 2.51% to Rs 508.20 per stock.

Last year, Strides Pharma was able to enter a sub-license agreement with the Medicines Patent Pool (MPP) for the marketing of a generic version of Pfizer’s Covid-19 oral drug Paxlovid.