Strides Pharma receives US regulator nod for HIV treatment drug

Drug firm, Strides Pharma Science Limited announced that its step-down wholly-owned subsidiary, Strides Pharma Global Private Limited (Singapore) has received approval for Emtricitabine & Tenofovir Disoproxil Fumarate tablets, 200 mg/300 mg from United States Food & Drug Administration (USFDA). 

The above-mentioned drug is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Truvada tablets, 200 mg/300 mg, of Gilead Sciences. The combination of the two slows down the spread of HIV in the body and is also used along with other medications to treat HIV. 

According to IQVIA MAT data for November 2020, the US market for Emtricitabine & Tenofovir Disoproxil Fumarate tablets, 200 mg/300 mg is approximately US$ 2.4 billion. The product will be manufactured at the company’s facility at Bengaluru and will be marketed by Strides Pharma Inc. in the US market. 

The company has 127 cumulative ANDA filings with USFDA so far, out of which, 95 ANDAs have been approved and 32 are still pending approval. 

At around noon on Friday, the stock of Strides Pharma Science was trading at Rs 919.25 per share, down by 0.23 per cent or Rs 2.10 per share on BSE, as against a 0.56 per cent decline in the benchmark index. The 52-week high was recorded at Rs 1,000 while its 52-week low was Rs 271 on BSE.