UK becomes first nation to approve antiviral Covid pill – FDA to wait till end of month


An antiviral drug that could slash hospitalizations and deaths from COVID-19 by half has received regulatory approval in the UK, the first country to green light the drug.

Molnupiravir, developed by the Kenilworth, New Jersey-based company Merck & Co., is garnering worldwide attention after promising results in the clinical trials.  

The drug will be administered to Covid patients in four pill doses, twice a day for five days upon a person feeling symptoms of the virus. 

While British patients will have access to the drug soon, it is pending regulatory approval in the U.S. and a meeting by the U.S. Food and Drug Administration (FDA) to discuss the drug’s merits isn’t scheduled until November 30. 

A study at the start of the month showed molnupiravir can cut hospitalizations and deaths by up to 50%. It works by disrupting the Covid virus's ability to reproduce in the human body

A study at the start of the month showed molnupiravir can cut hospitalizations and deaths by up to 50%. It works by disrupting the Covid virus’s ability to reproduce in the human body 

The United Kingdom is the first nation to approve the usage of molnupiravir (pictured). The FDA has an advisory meeting scheduled to discuss the fate of the drug on November 30, and Americans will have to wait at least till then to access the drug

The United Kingdom is the first nation to approve the usage of molnupiravir (pictured). The FDA has an advisory meeting scheduled to discuss the fate of the drug on November 30, and Americans will have to wait at least till then to access the drug 

‘The first global authorization of molnupiravir is a major achievement in Merck’s singular legacy of bringing forward breakthrough medicines and vaccines to address the world’s greatest health challenges,’ Robert Davis, Merck’s CEO, said in a statement.

British Health Secretary Sajid Javid called the treatment a ‘game changer’ for the most vulnerable. 

Britain has bought 480,000 doses of molnupiravir at a cost thought to be in the region of £250 million, or around $290 million.

What is molnupiravir? The antiviral drug described as a ‘game changer’

Who makes it?

Merck, the US pharmaceutical giant 

How effective is it? 

A recent trial of the pill in almost 800 patients found that molnupiravir cut hospitalisation and death rates in half for people at high risk of a severe illness from Covid. 

How much has the UK ordered?

480,000 courses

What does it cost? 

Merck has charged the US government about $700 (£500) per course of the drug. Though it is reported to cost just under £13 to make. 

How does it work?

The pill works by introducing errors into Covid’s genetic code to hamper its ability to multiply in human cells. 

It does so by attacking an enzyme that Covid uses to make copies of itself. Merck said that because of this, the tablet should be able to tackle new variants as it evolves.

Vaccines, which are being made slightly weaker by new strains of the virus, work by targeting the spike protein.

The drug will be sold under the brand name Lagevrio. 

It is expected to be rolled out on the National Health Service (NHS) within weeks, providing the country with an extra layer of defense heading into winter.

The pill will be given out to both vaccinated and unvaccinated Britons, and officials will collect extra real-world data before buying more. 

‘We are now working across government and the NHS to urgently get this treatment to patients initially through a national study so we can collect more data on how antivirals work in a mostly vaccinated population,’ Maggie Throup, the UK’s vaccine minister, told Parliament. 

The COVID-19 vaccines are still considered the most effective way to combat the virus, as they are safe and effective at preventing infection.

Molnupiravir is not to act as a vaccine replacement, but instead as another tool in the arsenal medical professionals will have to fight the virus. 

Americans will have to wait a little longer than their counterparts across the pond to use the drug.

The FDA has scheduled an advisory committee meeting to discuss the fate of molnupiravir on November 30.

Merck is seeking FDA emergency use authorization for the drug, the same level of approval the Covid vaccines initially received.

The company is also partnering with generic manufacturers around the world to mass-produce and distribute the drug.

In July, the company announced it would partner with generic manufacturers based in India to help make the drug widely available in the Covid struck nation.

The company also announced a partnership with the Medicines Patent Pool, a United Nations-backed public health organization, this week to help distribute the drug across over 100 other nations.

If the drug does get approval from regulators, then the U.S. has a deal in place to order 1.7 million doses.

France has also ordered 50,000 doses of the drug in advance of approval from regulators.

Davis told CNBC last month that Merck was prepared to distribute ten million doses of the drug by the end of the year if it received approval.

The drug works by blocking the virus from replicating in the body.

It does so by introducing errors into Covid’s genetic code, hampering its ability to multiply in human cells.

The medicine targets an enzyme that the virus relies on to generate copies of itself. Merck said this process should make the tablet equally effective at tackling new variants.

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