The Federal Commission for the Protection against Sanitary Risks (Cofepris) has authorized the sanitary registration of the drug Paxlovid manufactured by the Pfizer laboratory and which is one of the antivirals indicated for the treatment of covid in adults who do not require supplemental oxygen and who have a higher risk of progression of severe covid. The results of the agency’s technical analysis determine that Paxlovid meets all the quality, safety and efficacy requirements that allow it to authorize the open marketing of the drug. The decision makes Cofepris one of the first regulatory agencies to authorize Paxlovid for this type of sanitary registration.
In a statement, the agency said its decision is based on the evaluation of the Committee for New Molecules (CMN) and “the rigorous technical analysis carried out by its team,” who determined that the drug meets the requirements of quality, safety and efficacy, according to the information presented in the technical file.
Paxlovid is an antiviral that inhibits the protease (enzyme that breaks protein bonds) of SARS-CoV-2, the virus that causes Covid, and has already been approved by other regulatory institutions such as the United States Food and Drug Administration (FDA), Health Canada, the European Medicines Agency (EMA), the National Health Surveillance Agency of Brazil (Anvisa) and the National Agency of Medicines of Chile (Anamed). “The authorization in Mexico will allow us to continue advancing in the fight against Covid,” Cofepris said in a statement.
To administer this drug, which combines the antivirals Nirmatrelvir and Ritonavir, a medical prescription is required, and the treatment that uses it must always be under strict supervision. Cofepris has called for avoiding self-medication and the irregular sale of the drug.
At the end of 2021, a year after the coronavirus vaccines were approved, Pfizer announced that it had an effective treatment for Covid ready. Paxlovid showed in clinical trials that it could reduce hospitalizations by 89% in patients with the most serious prognosis. It seemed the ideal complement to immunization for the most vulnerable people and those whose lives are most at risk from the virus: people over 60 years of age with other pathologies. But since its use has been taken with caution, for example, in Spain, due to incompatibilities with other medicines.
The drug is specifically indicated for people at higher risk of a poor outcome of Covid: those over 60 years of age, often with comorbidities, which makes it more likely that they are taking one of the drugs with which it cannot be combined. According to Jesús Sierra, from the Spanish Society of Hospital Pharmacy, it is not always easy to stop a treatment to introduce Paxlovid, which has to be taken within five days of symptoms for it to be effective. “If, for example, you are taking statins for cholesterol, which are very common, there is no time to stop the drug and start with Paxlovid,” he said.
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