ECONOMYNEXT – An advisory committee on communicable diseases in Sri Lanka has approved the Molnupiravir anti-COVID drug, a health official said.
Director General of Health Services Dr Asela Gunawardena said the health ministry is awaiting official approval from the National Medicine Regulatory Authority (NMRA).
“After that, we will take the other measures,” Gunawardena told reporters on Monday (15).
Molnupiravir is the first oral antiviral medication for COVID-19. Jointly developed by U.S.-based Merck & Co Inc (MRK.N) and Ridgeback Biotherapeutics, the drug can be taken as a pill rather than being injected or given intravenously.
The drug, currently being evaluated by the World Health Organisation (WHO), needs to be given within five days of the onset of symptoms to be most effective.
“The medicine can be given to all patients that show mild to moderate symptoms and 800 milligram tablets need to be given twice a day,” State Minister of Pharmaceutical Production, Supply and Regulation Channa Jayasumana told reporters on Monday.
He said researchers have mentioned that a vaccinated person who gets infected with COVID-19 can also get good results with Molnupiravir.
International media quoted Merck & Co Inc that the phase three of the drug was studied with the participation of 1,550 patients globally in more than 170 planned sites in Argentina, Brazil, Canada, Chile, Colombia, Egypt, France, Germany, Guatemala, Israel, Italy, Japan, Mexico, Philippines, Poland, Russia, South Africa, Spain, Sweden, Taiwan, Ukraine, the United Kingdom and the United States.
Merk said the study showed that Molnupiravir reduced the risk of hospitalisation and/or death across all key subgroups. Efficacy was not affected by timing of symptom onset or underlying risk factor, the company said.
The most common risk factors for poor disease outcome included obesity, older age (>60 years), diabetes mellitus, and heart disease.
Additionally, based on participants with available viral sequencing data (approximately 40 percent of participants), molnupiravir demonstrated consistent efficacy across viral variants Gamma, Delta, and Mu variants.
To date, the Delta, Gamma, and Mu variants have accounted for nearly 80 percent of the evaluable cases in the trial. Recruitment in Latin America, Europe, and Africa accounted for 55 percent, 23 percent and 15 percent of the study population, respectively.
Even though approval has not yet been granted by the WHO or the US Food and Drug Administration (FDA), the United Kingdom gave approval for the drug on Thursday (04) and placed an order for 480,000 courses, with the first deliveries expected in November.
Merik said it expects to produce 10 million courses of treatment by the end of 2021, with more doses expected to be produced in 2022.
Earlier this year, Merck entered into a procurement agreement with the US government under which Merck will supply approximately 1.7 million courses of molnupiravir to the country, upon EUA or approval from the FDA, media reports said. (Colombo/Nov16/2021)