The National Health Surveillance Agency (Anvisa) approved the authorization for emergency use of molnupiravir, oral antiviral from pharmaceutical Merck – MSD in Brazil – against Covid-19. The request was made in November last year.
General Manager of Medicines and Biological Products, Gustavo Mendes presented data on the safety and efficacy of the treatment and made the recommendation for drug approval to the Agency’s Collegiate Board. “We consider the information regarding the product to be satisfactory, given that it has been approved by other regulatory agencies.” However, he warned that Anvisa should monitor uncertainties about the quality assessment, such as the stability of the active pharmaceutical ingredient (IFA) and the finished product and uncertainties about quality assessment.
Mendes highlighted that the drug cannot be used by pregnant women or while breastfeeding. Among the side effects are: nausea, migraine and headache.
The reporting director of Anvisa, Meiruze Sousa Freitas, said that the measures of mask use, social distancing and hand hygiene were important to avoid collapses during the pandemic, but that new actions must be incorporated. “The pandemic will only come under control with preventive measures, especially vaccination, and effective therapeutic tools with the possibility of broad access.”
She stressed that molnupiravir “addresses an unmet medical need and there are benefits to its immediate availability.”
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In a note, MSD informed that it is negotiating the transfer of antiviral technology so that the Oswaldo Cruz Foundation (Fiocruz) is responsible for production in the country. According to the company, the possibility of studies with the antiviral for viral infections, such as dengue and chikungunya, will also be analyzed.
“Conversations are advanced and the partnership will be made in stages, the first being focused on the distribution of molnupiravir to the SUS”, said Mário Ferrari, director of the Infectology business unit at MSD, in a press release.
A study presented by the pharmaceutical company, published in The New England Journal of Medicine, with patients in the initial phase of the disease, pointed out that the medication is capable of reducing severe cases and deaths by 30%. The drug is indicated for adults who are not hospitalized and who can progress to severe forms of the disease. The treatment period is five days after the onset of symptoms.
On March 30th, Anvisa released the emergency use of Pfizer’s Covid-19 oral antiviral drug, Paxlovid. The drug is indicated in the initial phase of the disease for patients at high risk of developing severe cases of the disease. Studies carried out by the pharmaceutical company showed that the drug is capable of reduce the risk of hospitalization and death by 89%. Research has indicated that the antiviral is also effective for omicron worry variant.
At the beginning of last month, the Ministry of Health approved the incorporation of baricitinibe for the treatment of Covid-19 in the Unified Health System (SUS).
First disease remedy to be incorporated into the system, the drug, for oral use, is indicated for hospitalized adults who need oxygen by mask or nasal catheter and cases of need for high oxygen flow or non-invasive ventilation. Double-blind, randomized, placebo-controlled studies with 2,500 participants showed that baricitinib showed potential for reduce mortality on day 28 of treatment by 38%. Treatment consists of one tablet a day for 14 days or until the patient is discharged.
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