Poland has purchased molnupiravir, a COVID medicine soon to be approved by the European Medicines Agency (EMA), Health Ministry spokesman Wojciech Andrusiewicz told TVN24 on Friday. He added the first tranche of the drug would most likely arrive in Poland in mid-December. "Of course we are also taking part in EU tenders for other medicines," he reassured.
EMA’s Committee for Medicinal Products for Human Use (CHMP) on Thursday approved two COVID-19 medicines: Ronapreve and Regkirona. The agency has advised allowing both drugs to enter the market, as clinical tests have shown they significantly lower the risk of hospitalisation and severe course of infection.
"EMA is reviewing available data on the use of molnupiravir (also known as MK 4482 or Lagevrio) to support national authorities who may decide on the use of this medicine for COVID-19 treatment prior to its authorisation," we read at the agency website.
"While the more comprehensive rolling review is ongoing ahead of a possible application for a marketing authorisation, EMA’s Committee for Medicinal Products for Human Use (CHMP) will provide EU-wide recommendations in the shortest possible timeframe to help national authorities decide on possible early use of the medicine, for example, in emergency use settings," the EMA added.
Asked when the medicines would be available in Poland, spokesman for Polish Health Ministry Wojciech Andrusiewicz said that talks with one of the producers regarding potential purchase were ongoing. "More important information at the moment, however, is that we are buying another drug which is to be approved by the European Medicines Agency next week. It's molnupiravir," he said.
"Dozens of thousands should arrive in Poland already in mid-December. (...) We've puchased this drug, signed a contract, as one of the first countries," the spokesman said. "Of course we are also taking part in EU tenders for other medicines," he reassured.
Molnupiravir is oral antiviral medicine, developed by Merck Sharp & Dohme in collaboration with Ridgeback Biotherapeutics, that reduces the ability of SARS CoV 2 (the virus that causes COVID-19) to multiply in the body. It does this by increasing the number of alterations (mutations) in the virus’s genetic material (known as RNA), in a way that impairs the ability of SARS-CoV-2 to multiply.
Merck's molnupiravir received its first regulatory approval globally, in the UK, last week. It is still under review in the United States and Europe.
Źródło: TVN24 News in English, TVN24, PAP, ema.europa.eu
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