Merck’s Covid-19 pill gets nod from Britain

Highlights

• Britain becomes the first country worldwide to approve Merck’s newly developed COVID-19 antiviral pill.
• Britain's MHRA recommended molnupiravir for high-risk patients, but this is the first approval given to an oral antiviral treatment.
• On 30 November, the safety and efficacy of the drug will be analysed by the US advisors, and there will also be a vote to assess if molnupiravir should be provided with authorisation.
  

Britain has become the first country worldwide to give its approval to the new Covid-19 antiviral pill, which has been developed by US-based Merck & Co Inc. and Ridgeback Biotherapeutics together. It will potentially be a game changer in the fight against the coronavirus pandemic.

For the people with mild Covid symptoms who had at least one risk factor for developing severe illness, like heart disease or diabetes, Britain's Medicines and Healthcare products Regulatory Agency (MHRA) recommends a drug called Molnupiravir. The regulator, after looking at the clinical data, said that the administration of the drug will take place in next five days.

However, the green light given to the new pill is the first one for an oral antiviral treatment and also the first one which will be widely administered to people. The drug will be used to fight Covid-19 across the community. On 30 November, the safety and efficacy of the drug will be analysed by the US advisors, and there will also be a vote to assess if Molnupiravir should be provided with authorisation. Branded as Lagevrio in Britain, the pill is used to alter the genetic code of the coronavirus to institute errors in it, and is dosage is twice a day for five days. Nevertheless, the drugs in molnupiravir’s class have been associated with birth defects in animal studies.

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Over 5.2 million people across the globe have succumbed to the pandemic and vaccines have been the sole focus in terms of treatment options. Other options, like the steroid dexamethasone and Gilead's infused antiviral remdesivir, are usually given only after the hospitalisation of patients.

Since last month, Merck's Molnupiravir is being keenly observed as data showed that the probability of being hospitalised or dying maybe be halved for people are at a higher risk due to comorbidities if the drug is administered in the early stages of illness. As Britain is moving towards the roughest winters it has ever witnessed, the national medical director for the National Health Service (NHS) in England, Professor Stephen Powis, said that high-risk patients would be administered the drug and it will be rolled out on a greater scale once its clinically approved for its usage leading to reduction in hospitalisations and death, and also for its cost effectiveness.

Pressure on the UK

The speedy approval for the drug in Britain comes amid the rising cases of infections. According to the latest seven-day average, around 40,000 cases of Covid-19 are recorded daily in Britain. This figure is second only to the US, which records 74,000 cases daily but has a population five times higher than Britain. The number of coronavirus cases are surging England, particularly the south-west region, as the cases among children are increasing at a high rate. The Covid-19 prevalence in England has hit a record high figure last month as per the data released on Wednesday.

The UK Government is under immense pressure for the implementation of its alternate plan, which focuses on the protection of NHS from unsustainable demand, which involves orders for working from home, passing on vaccines, and mask mandates. Other countries like Germany, France and Israel are also doing the same amid rising cases.

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The UK government claims that its aim at present is to administer vaccine boosters and inoculate children aged between 12 to 15 years. Britain and the drug manufacturer agreed to a deal to secure 480,000 courses of Molnupiravir in October. An independent pharmaceutical physician, Professor Penny Ward, welcomed the move, but said that the rollout plans need to be outlined in advance by the NHS and also warned that the strong global demand could lead to scarcity of the drug.

Bottom line

Amid the ongoing phase of the pandemic, pharmaceutical companies across the globe are a part of the treatment race. The production of around 10 million courses of the treatment is expected by Merck by the end of 2021, and at least of 20 million courses would be manufactured by the company in 2022. On Thursday, the shares of the US-based drug maker went up by 2.1% to close at US $90.54. Similar easy-to-administer antiviral pills are also being developed by Pfizer and Roche.

Despite no clarity that Britain will receive Merck’s doses, the company has promised global access for its drugs based on the paying capacity of countries, thus providing access to low-income countries as well.

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