Strides Pharma subsidiary gains FDA approval for EET tablets

Strides Pharma Science Limited has announced a significant achievement, with its wholly-owned subsidiary, Strides Pharma Global Pte. Limited in Singapore, receiving approval from the United States Food & Drug Administration (USFDA) for Efavirenz (600mg), Emtricitabine (200mg), Tenofovir Disproxil Fumarate (300mg) tablets, abbreviated as EET. This approval marks another milestone in Strides’ growing portfolio of products in the therapeutic category, with a total of 15 products approved through the PEPFAR pathway.

The EET tablet, which is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Atripla Tablets by Gilead Sciences LLC, holds a significant market opportunity in the United States, estimated at approximately US$7.5 million per IQVIA. Strides Pharma plans to manufacture this product at its state-of-the-art facility in Bengaluru.

What makes this approval even more noteworthy is that it qualifies Strides for participation in global donor-funded programs that procure this lifesaving medicine. EET Tablets are supplied to around 10 countries through such programs, with donor procurement for this product estimated at a value of approximately $15 million USD as of the full year 2022. This addition strengthens Strides’ offerings in the field of HIV treatment.

Currently, Strides Pharma boasts an impressive track record of 230+ approved ANDAs (Abbreviated New Drug Applications) out of 260 cumulative ANDA filings with the USFDA. Looking ahead, the company has set an ambitious target to launch around 60 new products in the United States over the next three years.

Strides’ EET tablets fall under the category of antiretrovirals and constitute a fixed-dose triple-drug combination medication designed for the treatment of HIV-1 infection in adult patients weighing at least 40 kilograms.