Friday, 03 July, 2020


European Union drug regulator endorses Gilead's remdesivir as COVID-19 treatment

India gives Hetero Labs and Cipla approval to make Gilead's COVID-19 drug Gilead Is Testing an Inhalable Form of Intravenous Remdesivir
Patty Aguilar | 29 June, 2020, 12:27

Regulator Drug Controller General of India (DCGI) has approved the generic versions made by Cipla and Hetero.

Remdesivir, an antiviral drug produced by Gilead Sciences, has become the first treatment for COVID-19 to receive the backing of the European Medicines Agency (EMA), according to an agency press release on Thursday.

"If the trials are successful, this could represent important progress".

"Remdesivir, our investigational antiviral medicine, is now given to patients intravenously through daily infusions in the hospital".

An inhaled formulation would be administered via a nebuliser, potentially allowing for easier administration outside of the hospital setting, and at earlier stages of disease.

Appetite for the antiviral drug remains high around the world, but investors have expressed concern about whether Gilead Sciences will be able to manufacture enough of it to adequately meet demand. It is priced at Rs 3,500 for 34 tablets, which is likely to be much lower than the price of Indian versions of Remdesivir dosages. The US Food and Drug Administration on May authorized remdesivir, an experimental antiviral drug, for emergency use to treat COVID-19.

The European medicines Agency (EMA) recommended conditional approval on sale anti - virus product ramdevpir as a drug for the treatment of COVID-19.

Combination studies and testing in additional patient groups are at the planning stages, said the CEO, noting that trials of remdesivir with anti-inflammatory drugs - Eli Lilly's JAK inhibitor Olumiant (baricitinib) and Roche's IL-6 blocker Actemra (tocilizumab) - will generate results in the coming months. A U.S. National Institute of Allergy and Infectious Diseases (NIAID) study found that the drug shortened recovery time by an average of four days, and a study of moderately ill patients (hospitalized but not requiring oxygen) found that those who received five days of treatment with remdesivir had better outcomes than those who received standard care. The Union Health Ministry in its fresh clinical management protocol for COVID-19 patients, has described the use of Remdesivir as investigational therapy.

While receiving full approval in Japan, at least two major United States studies also have shown that it can reduce the duration of hospital stays for Covid-19 patients.

Already many healthcare experts across the globe have questioned the success rate of antivirals in COVID-19 treatment and claims related to cure.

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