The Federal Commission for the Protection Against Sanitary Risks (Cofepris), authorized to emergency use the combination of drugs in injectable solution with the generic name bamlanivimab and etesevimab, which may be used in care actions for patients with COVID-19.
Who can receive the treatment?
The combination was licensed under the therapeutic indication for the treatment of mild to moderate coronavirus disease in adults and pediatric patients (12 years and older weighing at least 40 kilograms), with positive direct diagnostic test results for the SARS-CoV-2 virus. , and who present very high-risk comorbidities that are not controlled.
The most important thing to note is that this injectable combination for Covid-19 cases should only be administered on the recommendation of a specialist. General practitioners do not have the power to recommend it to their patients. In addition, you should not resort to self-medication because the results can be counterproductive.
It is not a substitute for vaccines
It is also indicated that this new treatment alternative does not replace the licensed vaccines against Covid-19. Therefore, patients who receive this option are also candidates for the immunization that corresponds to them.
This authorization for emergency use is issued after an evaluation by Cofepris specialized opinion-giving staff, which focuses on meeting the necessary requirements to guarantee quality, safety and efficacy in the components.
Cofepris issues authorization for emergency use
injectable combination to treat # COVID19 💉The drugs bamlanivimab and etesevimab may be used in adult and pediatric patients following the therapeutic indication, get to know it 👇 https://t.co/oowAlgRHop pic.twitter.com/4vsnyKIkeu
– COFEPRIS (@COFEPRIS) December 1, 2021
As part of the approval process, experts from the New Molecules Committee (CMN) held an extraordinary session where they issued a non-binding unanimous favorable opinion on the combination of drugs, which was integrated into the file submitted by the pharmaceutical company. Eli Lilly and Company.
The authorization for emergency use is provisional, in support of care actions for the pandemic. However, Cofepris affirms that it will continue with the review of the file presented, and once the termination of the health emergency is decreed, the corresponding resolution will be issued in accordance with evidence and applicable legal provisions.
In this way, Cofepris joins the call of other health agencies in the world that have also approved bamlanivimab and etesevimab. Among the most prominent are the United States Food and Drug Administration (FDA).