Shares of Aurobindo Pharma hit a 52-week high of Rs 1,058 on 22 November after the company’s subsidiary received approval from the USFDA (US Food and Drug Administration).

In its regulatory filing, the company said that its subsidiary, Acrotech Biopharma, along with Evive Biotech, has received approval from the USFDA for the Ryzenuta injection that is used to treat chemotherapy-induced neutropenia.

The approval was granted based on the results of the two important Phase 3 studies completed in the US and Europe.

Ryzneuta injection is used to treat chemotherapy-induced neutropenia (CIN). Neutropenia is a condition that can arise due to the side effects of chemotherapy in a few patients. This is characterised by consistently low levels of neutrophils (a type of white blood cell with infection-fighting functions) due to the use of chemotherapy and other anti-cancer drugs.

Simon Li, CEO and CMO of Evive Biotech, said, “Ryzneuta is the first innovative biologics independently developed by Evive Biotech.”

Dr. Ashish Anvekar, President of Acrotech Biopharma, said, “Acrotech is very excited on the approval of Ryzneuta and is preparing to commercialise the product in the near future. We believe Ryzneuta will offer patients suffering from CIN a very compelling and accessible treatment option. We will leverage our strong and wellestablished commercial footprint to promote this unique treatment to key stakeholders.”

The company expects that the drug will receive further regulatory clearance to enable the medicine to help and provide patients worldwide with an effective first-line treatment and alternative therapy.

At 3:21 pm, the shares of Aurobindo Pharma were trading 2.76% higher at Rs 1,055.85 on NSE.