Health Canada gives the green light to the remdésivir

Santé Canada donne son feu vert au remdésivir

The Associated Press / HO Gilead Science
Even if Health Canada has approved the remdésivir, few patients with COVID-19 the will be prescribed since the drug is for patients whose state of health is serious and that they must respond to several criteria.

The hospitals in the country will have a new weapon against the COVID-19, the antiviral remdésivir, including the use of some patients has received the green light from Health Canada Tuesday. It is the first medicine to be approved by the federal agency to treat the virus.

“We don’t have much to combat this disease. The more we have, the better it is “, launches from the outset, the president of the Ordre des pharmaciens du Québec, Bertrand Bolduc. He stressed, however, that the use of the product remains, for the moment, ” rather limited “.

Because they do not receive the remdésivir who wants to. First, because it can only be administered intravenously and in care facilities where patients can be ” monitored closely “, says Health Canada.

Eligible patients must present a “serious symptoms” of the COVID-19. They must also be suffering from pneumonia and the need for additional intake of oxygen to help them breathe. Either through a mask or, in the case of the heavier, an artificial respirator.

Patients must also be aged over 12 years of age and weigh at least 40 pounds. The conditional permission issued Tuesday, does not apply to pregnant women.

Second wave

These criteria reduce significantly the pool of potential candidates, resumes Bertrand Bolduc. “The number of cases in the intensive care unit is minimal “, he notes. Quebec had just eight on Tuesday, a person less than the previous day.

This “tool” further is ” good news “, he insists. “If there’s a second wave, or that the virus mutates and becomes more difficult to combat, we will be able to use this medicine. “

“This is a step in the right direction, but it is not the panacea, says from his side, Dr. Cécile Tremblay, microbiologist-infectiologist at the CHUM. There is still a need to develop other drugs that will be able to be given to other phases of the disease and that can be even more effective. “

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Not to mention that the world’s stocks of remdésivir are ” very weak “, warned in a press briefing Dr. Theresa Tam, director-in-chief of the public health agency of Canada. The antiviral drug will be manufactured in country by a subsidiary of the american laboratory, which has developed, Gilead Sciences.

As a reminder, the us president has already announced that he would hand over 92 % of the production of the drug. This represents 500 000 treatments on the 550 000 that is required to produce a pharmaceutical firm between July and September.

Clinical trial

The remdésivir — which will bear the brand name Veklury — was first made in the fight against Ebola.

The “mechanism of action of this drug is an analogous of nucleoside, which is intended to prevent viral replication in infected cells,” explains Dr. Tremblay. Since ” this mechanism is quite universal for many types of viruses “, the researchers wondered if he could take action against the SARS-CoV-2. “What has been demonstrated “, she says, even though the effects are considered to be modest.

The antiviral has indeed passed under the magnifying glass of a phase III clinical trial in the month of February. The study was conducted by the National Institute for Allergy and Infectious Diseases of the United States from 1063 participants with the COVID-19.

According to it, the remdésivir has reduced the duration of hospitalization of at least three days in patients displaying signs of infection of the lower respiratory tract compared to placebo. However, it has not had a significant impact on the mortality rate.

The results were published a few weeks ago in the medical journal The New England Journal of Medicine.

Based on these findings, several countries, including the United States and Japan, and the european Commission, approved a conditional use or emergency medicine in the hospitals. Canada has followed suit on Tuesday, after having scrutinized the available data on the remdésivir.

At the end of this expedited review to six weeks, “the benefits of the drug outweigh its risks when used for approved indications,” said Health Canada.

The federal agency promises to ensure the safety of the remdésivir. Clinical trials are also in progress on the product, to see whether it can be combined with other drugs.

The balance of the day

The balance sheet of the pandemic coronavirus has increased Tuesday of 169 infections and 2 deaths in Quebec. There are now 58 897 deaths and 5670 dead, when one takes account of a death additional, which occurred prior to July 20. The number of hospitalizations has decreased by 7, at 193. 8 people are in intensive care, one more than the day before. It has 28 520 infections in the region of Montréal (+88), 6017 in Laval (+19) and 8699 in Montérégie (+18).

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