Merck’s oral antiviral pill grabs UK’s Emergency Use Approval in adults

UNITED KINGDOM – Britain has become the first country in the world to approve a potentially game-changing COVID-19 antiviral oral pill developed in collaboration by Merck and Ridgeback Biotherapeutics, providing a boost to the fight against the pandemic.

Experts believe that if widely approved, the medicine has enormous potential to aid in the fight against the coronavirus pandemic: pills are easier to take, manufacture, and store, making them especially useful in low- to middle-income countries with limited infrastructure and vaccine supplies.

We will continue to move with both rigor and urgency to bring molnupiravir to patients around the world as quickly as possible,” Merck President Robert M. Davis said.

The Medicines and Healthcare products Regulatory Agency (MHRA) advised using molnupiravir as soon as possible after a positive COVID-19 test and within five days of the onset of symptoms.

In due course, the government and the National Health Services (NHS) will confirm how this COVID-19 treatment will be administered to patients.

The company has applied for emergency use authorization with the US Food and Drug Administration, and the European Medicines Agency has begun a rolling review of the drug. Merck also stated that it was working on submitting applications to other regulatory agencies.

Merck, which worked on the drug with partner Ridgeback Biotherapeutics, announced last month that a global clinical trial showed the pill reduced hospitalizations and deaths by nearly half among higher-risk adult coronavirus patients with mild to moderate illness.

The trial’s first dose was administered to a volunteer in the United Kingdom. UK became the first country in the world to approve a coronavirus vaccine that had been tested in a large clinical trial when it granted emergency-use authorization to the Pfizer-BioNTech vaccine.

The US government has pre-purchased 1.7 million courses of Molnupiravir for approximately US$1.2 billion, or US$700 per treatment course. Purchase agreements have also been signed by Australia, Singapore, and South Korea.

Separately, Merck stated that it expects to produce 10 million courses of the treatment by the end of this year, with at least 20 million courses produced in 2022.

Merck stated that it will use a “tiered pricing approach” that considers each country’s ability to pay for the drug.

The company has also agreed to share its pill license with several Indian drugmakers and a United Nation’s-backed non-profit organization- Medicines Patent Pool (MPP), allowing the drug to be manufactured globally and increasing access to over 100 low- and middle-income countries.

The move stood out in the midst of a pandemic in which drug companies have been lobbying to retain rights to vaccines.

However, some advocacy groups have criticized Merck for excluding upper-middle-income countries that have been hard hit by the pandemic.

Molnupiravir works by introducing genetic mutations into the coronavirus’s genetic code, preventing it from replicating itself.

Virologists are hopeful that, in addition to lowering the risk of developing severe illness, the drug will help reduce virus transmission.

When compared to monoclonal antibodies, a costly treatment that is infused or injected, the pill is significantly easier to use.

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