An anti-viral drug that was initially developed to combat Ebola has been given emergency use authorization (EUA) by the US Food and Drug Administration (FDA) to treat coronavirus. This temporary measure does not mean that the medication has been formally approved as a treatment, although it will now be made available to hospitalized patients after initial studies indicated that it can speed up recovery time.
The drug, called remdesivir, was recently found to reduce the amount of time that Covid-19-infected patients needed to remain in hospital by 31 percent. Conducted by the National Institute of Allergy and Infectious Diseases (NIAID), the study found that those treated with the drug had an average recovery time of 11 days, while patients who received a placebo took 15 days to overcome their symptoms.
Results also revealed a slightly increased survival rate among those who were administered remdesivir, with this group experiencing a mortality rate of 8 percent. In comparison, the group that received the placebo had a mortality rate of 11.6 percent.
While full details of this Phase 3 clinical trial are yet to be released, the drug’s manufacturer Gilead says it is also conducting its own clinical studies into the safety and efficacy of various doses of remdesivir as a treatment for coronavirus.
However, the company stresses that “remdesivir is an investigational drug that has not been approved by the FDA for any use,” adding that “it is not yet known if remdesivir is safe and effective for the treatment of Covid-19.”
In spite of this, the EUA means that remdesivir can, for the time being, be administered to hospitalized patients with severe coronavirus symptoms. Gilead has pledged to donate its entire existing stock of the drug to American hospitals, adding up to 1.5 million vials.
While further trials are needed to determine the most effective dose of remdesivir, Gilead is recommending a 10-day course of treatment for patients requiring the use of a ventilator, and a five-day course for those who are able to breathe unassisted. Current supplies should be sufficient to deliver some 140,000 10-day treatment courses, which the government will distribute to those hospitals with the greatest need.
Meanwhile, Gilead is preparing to increase its production of the drug and is aiming to supply 500,000 10-day courses by October and 1 million by December.
While remdesivir was initially developed to treat Ebola, studies found it to be less effective than other anti-viral medications, and it was consequently shelved. Concerns have also been raised about the drug’s potential to cause harmful side-effects, with altered liver enzymes being one of the unwanted consequences occasionally seen in those treated with remdesivir.
