CHMP backs approval of remdesivir as COVID-19 treatment

Henrietta Strickland
June 29, 2020

Since then, another phase 3 trial has shown that a five-day treatment course with remdesivir on top of standard care was more effective than standard care alone in moderately-ill patients, although strangely a 10-day course wasn't any better.

The EMA said that the current data on remdesivir was assessed in an "exceptionally short timeframe" through a "rolling review" procedure, an approach used by the agency during public health emergencies to assess data as they become available.

The company is sure about enough stock to provide to the present requirements of the drug.

Dr. M. Srinivasa Reddy stated that "Covifor is Remdesivir's first generic brand. Through Covifor, we hope to reduce the treatment time of a patient in a hospital, thereby reducing the increasing pressure on the medical infrastructure, overburdened now due to accelerating COVID-19 cases", Hetero Healthcare MD M. Srinivasa Reddy said.

On Sunday, Hetero said it has received the manufacturing and marketing approval for remdesivir from the Drug Controller General of India (DCGI) for the treatment of COVID-19. The cost of the product is Rs 5,400 per bottle. Hetero supplied its first batch of the vials to states such as Maharashtra, Delhi, Gujarat, Tamil Nadu and Telengana.

The other lot will be supplied to Kolkata, Indore, Bhopal, Lucknow, Patna, Bhubaneshwar, Ranchi, Vijayawada, Cochin, Trivandrum and Goa within a week, it added.

A drug originally developed to treat Ebola is now set to be used for treating COVID-19 patients in the EU, after receiving the green light from the European Medicines Agency (EMA). Notably, Gilead Sciences is the patent holder of this drug.

The capital of Hyderabad, Telangana, where the company is based, will also receive the first batch of the drug.

"Remdesivir is the first medicine against COVID-19 to be recommended for authorisation in the European Union", the agency said.

Along with Hetero, three Indian companies, including Cipla, Jubilant, and the domestic arm of Mylan, have signed non-exclusive voluntary licencing agreements with Gilead Sciences.

A prior study in the USA, headed by the National Institutes of Health recently discovered it provokes an average recovery period from 15 days to 11 times in hospitalized patients with acute illness.

Other reports by Click Lancashire

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