Green light in Europe for the first specific drug against covid-19. The European Medicines Agency (EMA) has recommended that remdesivir, an antiviral that prevents the virus from replicating in the body, be authorized for marketing to treat patients with covid-19 who are in a state serious. Specifically, the indication is for adults and adolescents from 12 years of age with pneumonia who require supplemental oxygen.
The EMA’s recommendation is based mainly on the preliminary results of the largest study carried out to date with this drug and published in the New England Journal of Medicine (NEJM), which had concluded that with this drug, patients recovered a average of four days before the rest of the patients. The US EMA’s counterpart, the FDA, had already approved the use of remdesivir to treat covid-19 in early May via the emergency route.
The community agency has approved recommending that Veklury (remdesivir) be granted a conditional marketing authorization following a meeting Thursday in Amsterdam. This permit allows a medicine to be sold throughout the European Union before even having all the data on efficacy and side effects if it is found to have more benefits than risks for the patient.
Californian company Gilead’s request reached the EMA just a couple of weeks ago. The speed of approval is due to the fact that the EMA had already launched an analysis on the use of this antiviral for the specific treatment of covid-19 on April 30, using a procedure available to accelerate the evaluation of medications. that are promising in case of a health emergency. “Considering the available data, the agency considered that the balance of benefits and risks had been shown to be positive in pneumonia patients who require supplemental oxygen.”
The Commission, which according to the EMA has been permanently informed, will speed up the decision procedure to give the green light to the approval of remdesivir next week. No specific drug for covid-19 had yet been approved in Europe, although healthcare professionals used an arsenal of drugs that had other indications to treat the infectious disease, such as monoclonal antibodies or dexamethasone, a corticosteroid for rheumatic or autoimmune diseases. . “It is the first specific antiviral for covid-19,” says Benito Almirante, head of the Infectious Diseases service at the Vall d’Hebron hospital in Barcelona.
Remdesivir was only used in the context of clinical trials – Val d’Hebron was administered to a dozen patients in this context – and for compassionate use (for exceptional cases, before being authorized and when there is no other therapeutic alternative). In Spain, the Spanish Agency for Medicines and Health Products (AEMPS) only allowed compassionate use from March 30 to pregnant women and children, but, as of May 20, it extended the spectrum to all hospitalized patients with serious illness.
According to several statements issued since last April 30 by the EMA, during that review, the committee that addresses human medications evaluated data on the quality and manufacture and preliminary results of several clinical studies. After that study was completed, he invited Gilead to send the agency more information along with a request for conditional marketing authorization (CMA).
In recent months, three scientific articles have been published in the NEJM that endorse the efficacy of remdesivir and one in The Lancet that finds no benefits. The negative trial, conducted with 237 patients treated in China, showed that remdesivir was of no benefit. However, the first from the NEJM, published May 22, was the preliminary results of an international study with 1,065 patients and funded by the United States National Institute of Infectious Diseases (NIAID), which showed that mortality and recovery time (from 15 days in the placebo group to 11 in patients treated with remdesivir).
The second NEJM, dated May 27 and financed by Gilead, concluded that there were no significant differences between treating patients for five or 10 days. And the third, with 53 patients in compassionate use and also paid by the pharmaceutical company that markets it, concluded that there had been clinical improvements in 68% of the patients.