Drug firm Strides Pharma Science Ltd on Wednesday (October 4) said it's subsidiary Strides Pharma Global Pte Ltd has received approval from the United States Food & Drug Administration (USFDA) for efavirenz, emtricitabine and tenofovir disoproxil fumurate tablets.
The approval is for efavirenz (600 mg), emtricitabine (200 mg), tenofovir disproxil fumarate (300 mg) tablets, commonly referred to as EET tablets, under the expedited review provision for the President's Emergency Plan for AIDS Relief (PEPFAR), according to a stock exchange filing.
This is a significant milestone for Strides Pharma as the product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Atripla tablets, which is manufactured by Gilead Sciences LLC. The approval also underscores Strides Pharma's commitment to advancing HIV treatment options.
The EET tablet is poised for a substantial market opportunity in the United States, estimated at $7.5 million, according to IQVIA. Strides Pharma will manufacture this medication at its facility in Bengaluru, India.
One of the most notable aspects of this approval is that it qualifies Strides Pharma to participate in global donor-funded programmes that procure lifesaving medicines like EET tablets.
These medicines are supplied to approximately 10 countries, and as of the full year 2022, donor procurement for EET tablets is estimated at approximately $15 million.
Strides Pharma has been actively expanding its portfolio in the United States and currently has 260 cumulative Abbreviated New Drug Application (ANDA) filings with the USFDA, which includes the recently acquired portfolio from Endo at Chestnut Ridge.
Of these filings, more than 230 ANDAs have already received approval. The company has set an ambitious goal to launch 60 new products over the next three years in the US market.
The EET tablets developed by Strides Pharma belong to a class of medication known as antiretrovirals. This fixed-dose triple-drug combination medication is indicated for the treatment of HIV-1 infection in adult patients weighing at least 40 kilograms.
The approval of this medication contributes to the availability of effective treatment options for individuals living with HIV, furthering Strides Pharma's mission to improve global healthcare access.
Shares of Strides Pharma Science Ltd ended at Rs 508.20, up by Rs 12.45, or 2.51 percent, on the BSE.
