The European Commission on Friday granted conditional approval of the drug Remdesivir for the treatment of patients with coronavirus.
This is done after the EU Medicines Agency (EMA) recommended end-June approval. Formally, the European Commission approves medicine in the EU.
“Today’s approval of the first drug to treat Covid-19 is an important step in combating this virus,” EU Health Commissioner Stella Kyriakides said in a press release.
A conditional approval can be granted in the case of a very serious illness where there are no drugs to treat it.
The approval means that the medicine can be marketed in the EU for the treatment of patients from the age of 12 who are ill with coronavirus with the need for artificially administered oxygen.
Clinical trials have shown that the drug for this group of pulmonary patients on average can reduce the hospitalization time from 15 to 11 days.
Approval happened very quickly. It has taken less than a month, from the application from the manufacturer Gilead, until it was ready.
The Medicines Agency’s medical chief, Nikolai Brun, recently told Ritzau that it was the quickest approval he knew of.
On Wednesday this week, it emerged that the United States has purchased 100 percent of the total production of the drug in July and 90 percent of production in August and September.
On Thursday, a spokeswoman for the European Commission announced that it was negotiating with Gilead to ensure doses of the drug for all EU countries.
However, the medicine has already been used in hospitals. This also applies in Denmark. This is because, according to Nikolai Brun, Danish hospitals have participated in the trials that led to the approval.
“So they have been helping to generate the data that has now triggered a recommendation for approval,” Nikolai Brun said on June 25.
In addition, EMA has previously approved the substance under the so-called compassionate use program. This was done to ‘cover the need until approval was granted’.
/ Ritzau /