DGCI approval for manufacturing, marketing of Remdesivir:Hetero

Henrietta Brewer
June 29, 2020

Cipla shares towered over 9 percent to hit a career-high on Monday after the company informed stock exchanges that it had received approval from the government's Drug Controller General of India (DCGI).

"After receiving the green light from the FDA to move forward, Gilead is about to start trials of an inhaled version of Remdesivir".

Covifor, the generic version of Covid-19 drug Remdesivir, will be available in India for Rs 5,400 per 100 mg vial, Hyderabad-based Hetero Labs announced on Wednesday.

"If the trials are successful, this could represent important progress". It needs to be administered intravenously in a hospital, critical care setting, under the supervision of a registered medical practitioner. "That could have significant implications in helping to stem the tide of the pandemic", he said.

Demand for the drug soared after it became a front-runner following promising trials. It is but to be priced within the United States.

Remdesivir, which is made by Gilead, is now being used to treat COVID-19 patients worldwide. The investigational antiviral drug remdesivir has been explored as a treatment for several indications, including Ebola, severe acute respiratory syndrome (SARS), Marburg, Middle East respiratory syndrome (MERS) - and most recently COVID-19.

Remdesivir is the first drug said to have shown to be effective against the coronavirus in human trials.

The course of drugs was the first to display improvement during the trials on coronavirus patients and has gotten consent for urgent use in seriously ill patients in the United States and South Korea, and got full approval in Japan.

According to the EMA, COVID-19 patients who are in need of supplementary oxygen should be given remdesivir for no more than nine days. Now Glenmark is planning a large clinical trial with 1,000 patients to prove its efficacy and safety to take the drug to overseas markets and a big launch in India. The preliminary report was based on data obtained from the Adaptive COVID-19 Treatment Trial (ACTT), a double-blind, randomized, placebo-controlled trial, sponsored by the National Institute of Allergy and Infectious Diseases (NIAID).

"Last week's news on dexamethasone appears to further support the study of complementary approaches for treating COVID-19".

Other reports by iNewsToday