US FDA approves remdesivir as first drug for Covid-19

The US Food and Drug Administration on Friday approved remdesivir citing three clinical trials including one by the US National Institutes of Allergies and Infectious Disease

According to the press release by the company, previously authorised by the FDA for only emergency use to treat COVID-19 patients, Veklury or Remdesivir is now the first and only approved COVID-19 treatment in the United States.

In a statement, the FDA announced that approval had been granted for Veklury, the brand name of the remdesivir drug, for use in adult and paediatric patients aged 12 and older and weighing at least 40kg (just over six stone).

The World Health Organization, however, found last week that the drug failed to reduce deaths among patients or cut the duration of their treatment in hospitals.

Remdesivir, which is administered by an injection, was one of the first drugs to show relative promise in shortening the time to recovery in some coronavirus patients.

The Food and Drug Administration has approved remdesivir as a treatment for the coronavirus. Gilead becomes the first and only company to receive approval for a COVID-19 treatment in the USA, according to the company's press release.

"Today's approval is supported by data from multiple clinical trials that the agency has rigorously assessed and represents an important scientific milestone in the COVID-19 pandemic", said FDA Commissioner Stephen Hahn, MD, in the agency's announcement.

The FDA considered two studies, one which was in the favor of the drug and the other which shows that this drug does not make much of a difference. It is usually given over five days and works by helping to stop the replication of COVID-19 in the body.

Remdesivir is used in the treatment of Covid-19. As a secondary endpoint, remdesivir also reduced disease progression in patients needing oxygen, resulting in a significantly lower incidence of new mechanical ventilation or ECMO (13% vs. 23%; 95% CI, -15 to -4).

As the Covid case rate spikes again for the third time this year - and the seven-day average has surged past 60,000 new daily cases - Gilead said it is ramping up production to try to meet the growing case load and hospitalizations. Patients with moderate disease who received a five-day course of remdesivir were 65% more likely to experience clinical improvement compared with a standard-of-care group. It involved 11,266 patients across over 30 countries. "On the other hand, the (US-NIAID) trial looked at time to recovery".

The incidence of adverse events (AEs) associated with remdesivir was similar to placebo in the ACTT-1 trial. It's also not clear how sick the patients in that study were and therefore how meaningful the results are. The most common side effects are nausea and elevated liver enzymes, according to the product's label.