(Reuters) – The European Medicines Agency (EMA) on Friday recommended Gilead Sciences Inc’s investigational antiviral drug remdesivir should be used for treating COVID-19 in compassionate use programmes.
Compassionate use is the use of an unauthorised medicine outside a clinical study in individual patients under strictly-controlled conditions.
The EMA said https://bit.ly/2xPfFww remdesivir has been shown to be active against the new coronavirus that causes COVID-19 in laboratory studies, but added there were limited data on its effectiveness.
Remdesivir, which previously failed as an Ebola treatment, has been described by U.S. President Donald Trump and other health officials as one of the more promising candidates to fight the coronavirus.
“The CHMP (EMA’s Committee for Medicinal Products for Human Use) encourages the company to make remdesivir available in a fair and transparent way to those member States wishing to take part in international clinical trials or treat patients in compassionate use programmes,” EMA said.
In late March, Gilead asked the U.S. Food and Drug Administration to rescind a controversial orphan drug designation the agency had granted for remdesivir.
(Reporting by Muvija M in Bengaluru; Editing by Ramakrishnan M.)