Merck and its partner Ridgeback Biotherapeutics announced on Monday that they’ve submitted an emergency authorization application to the US Food and Drug Administration (FDA) for their oral antiviral Covid treatment molnupiravir.
The US-based pharmaceutical company revealed the request had been made to the FDA, with the hope that it will become the first authorized oral antiviral Covid treatment following positive results from Merck’s Phase 3 clinical trial.
“The extraordinary impact of this pandemic demands that we move with unprecedented urgency, and that is what our teams have done by submitting this application for molnupiravir to the FDA within 10 days of receiving the data,” Merck’s chief executive officer and president, Robert M. Davis, stated in a press release on the company’s website.
Merck described the development as a “critical step” towards making the treatment available to individuals at home, reducing the risk of severe illness and cutting in half the hospitalization rates among individuals infected with the virus.
In the hope that the drug will be given the green light by the FDA, Merck has already begun producing the treatment, expecting to have 10 million courses of molnupiravir ready for distribution by the end of 2021, with more due in 2022.
Anticipating Merck’s successful trials, the US government ordered 1.7 million courses of molnupiravir, as part of a procurement agreement earlier this year, with other supply and advance-purchase deals similarly signed off with countries around the world.
To help boost the production of the treatment, allowing it to be more quickly distributed in low and middle income countries, Merck has agreed a non-exclusive voluntary licensing agreement with Indian manufacturers, hoping to secure authorization to ensure widespread access to the medicine.
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source: RT
Împotriva articolelor redacției noastre, persoanele nemulțumite pot formula Contestație în termen de 10 zile de la publicarea articolului, la judecătoria Orășenească nr. 1 München Bayern Deutschland, in conformitate cu Legea federală Germană. Considerăm că nu se pot formula acțiuni la instanțele din România deoarece nici o persoană care activează în trustul nostru nu poate fi extrasă de sub jurisdicția federală germană. Considerăm că redacția noastră nu răspunde în fața autorităților din România ci doar celor federale sau civile germane. deoarece legea română nu are efecte de extraneitate asupra redacției chiar dacă subiectul știrilor face obiectul unor evenimente sau persoane din România și sunt scrise în limba română. Limba română nu este izvor de extraneitate a legii.
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