AstraZeneca Pharma India surrenders marketing authorisation of prostate cancer drug, shares rise 4%

At 2:08 PM, shares of Astrazeneca Pharma India were trading 4.79% higher at ₹8,862.50 apiece on the National Stock Exchange. The shares have seen a strong uptick of 16% in the last 5 days.

Over a month’s period, shares of Astrazeneca Pharma have gained 12.06%. Additionally, the current market capitalisation of the company stands at ₹22,160 crore.

The company had received marketing authorisation for Olaparib film-coated tablets 100mg and 150mg (Lynparza) on November 17, 2023, AstraZeneca Pharma India said in a regulatory filing. It has now surrendered the marketing authorisation of the indication of Olaparib (Lynparza) 100mg and 150mg, the filing added.

"...since the date of receipt of marketing authorisation for the said indications i.e. November 17, 2023, till date, we have never marketed the said indication in India," the company said, adding, "the discontinuation decision is only on the basis of commercial reasons and is not due to efficacy or safety reasons."

The drug is indicated in combination with Abiraterone and Prednisone or Prednisolone for the treatment of adult patients with metastatic castration-resistant prostate cancer, AstraZeneca Pharma India said, adding, it continues "to hold all other existing permissions for the said drug Olaparib in India".

On March 7, the drug company had received approval from the Central Drugs Standard Control Organisation (CDSCO) to import, sell, and distribute durvalumab (Imfinzi) solution for infusion in 120 mg/2.4 ml and 500 mg/10 ml doses for an additional indication.

AstraZeneca Pharma India, the Indian arm of the UK-based global pharmaceutical company AstraZeneca, has been active in areas such as oncology, cardiovascular, renal, and metabolic diseases. The company remains a significant player in the Indian pharmaceutical sector and continues to introduce innovative therapies across various therapeutic segments.