The European Medicines Agency (EMA) – the European Union’s top medicines watchdog – has started a review of a potentially ground-breaking antiviral pill to treat COVID-19.
The agency announced on Monday that it has launched a “rolling review” of molnupiravir, which was developed by United States pharmaceutical company Merck.
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The company reported earlier this month that the pill cut hospitalisations and deaths by half among patients with early symptoms of COVID-19 – an extremely effective result that experts say could revolutionise the global fight against the coronavirus pandemic.
Earlier on Monday, Merck said the EMA had started an expedited licensing process for molnupiravir.
Merck has already sought approval for the pill from the US Food and Drug Administration. A decision is expected from the US agency within weeks.
If molnupiravir is approved by either regulatory body, it will become the first available treatment for COVID-19 that does not need to be administered via needles or intravenous infusions.
Public health experts say that having a pill that people can take at home to reduce their symptoms and speed recovery could vastly ease pressures on hospitals and help to curb outbreaks in poorer countries with weak healthcare systems.
If approved, countries could take a two-pronged approach to battling the pandemic – reducing the risk to those who contract the virus, while continuing vaccine rollouts.
However, international health officials have already voiced concerns that the pill could be subject to the same disparities that have defined the rollout of COVID-19 vaccines.
Merck – which already has supply deals with the US, the United Kingdom, Australia, Malaysia and Singapore – has said it is committed to providing timely access to its drug globally with plans for tiered pricing aligned with a country’s ability to pay.
Last week, a spokesperson told Reuters that the company has taken the unusual step of seeking to license several generic versions of molnupiravir even before its branded version is authorised for marketing “to build sufficient global supply of quality-assured product to orders globally”.