UK first to approve antiviral pill for COVID-19

UK first to approve antiviral pill for COVID-19
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The antiviral pill known as Lagevrio (molnupiravir) has now been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) for use in the UK.

Lagevrio (molnupiravir) is a safe and effective antiviral pill that can reduce the risk of hospitalisation and death in people with mild to moderate COVID-19 who are at increased risk of developing severe disease according to the MHRA.

The antiviral pill was developed by Ridgeback Biotherapeutics and Merck Sharp & Dohme (MSD). Lagevrio works by interfering with the virus’ replication. As a result, it prevents it from multiplying, keeping virus levels low in the body and reducing the severity of the disease.

The first oral antiviral pill for COVID-19

Lagevrio will be advised for use in adults who have developed mild to moderate COVID-19. The recommended dose is 800mg which is a total of four 200mg capsules, taken orally every 12 hours for five days. However, adults with certain risk factors such as obesity, older age (>60 years), diabetes mellitus or heart disease will be offered the antiviral COVID-19 pill.

It is outlined that if you miss a dose of the antiviral pill by more than 10 hours, patients should not take the missed pill and take the next dose at the regularly scheduled time. There is flexibility with taking Lagevrio, and individuals can take the missing dose within 10 hours of the scheduled time.

However, this oral antiviral pill should not be used as a substitute for vaccination against COVID-19.

Health and Social Care Secretary Sajid Javid said: “The UK is leading the way to research, develop and roll out the most exciting, cutting-edge treatments, and my thanks goes to the expert teams at the MHRA and MSD for this triumph, as well as the Antivirals Taskforce who have procured the treatment.

“We are working at pace across the government and with the NHS to set out plans to deploy molnupiravir to patients through a national study as soon as possible.

“This antiviral will be an excellent addition to our armoury against COVID-19, and it remains vital everyone comes forward for their life-saving COVID-19 vaccine – particularly those eligible for a booster – to ensure as many people as possible are protected over the coming months.”

The safety and effectiveness of Lagevrio

The oral pill has been approved after a rigorous review of its safety, quality and effectiveness by the UK regulator and the government’s independent expert scientific advisory body, the Commission on Human Medicines. Based on the clinical trial data, Lagevrio is most effective when taken in the early stages of infection; therefore, the MHRA recommends it should be used following a positive COVID-19 test and within five days of symptoms appearing.

Dr June Raine, MHRA Chief Executive, said: “Following a rigorous review of the data by our expert scientists and clinicians, we are satisfied that Lagevrio (molnupiravir) is safe and effective for those at risk of developing severe COVID-19 disease and have granted its approval.

“Lagevrio is another therapeutic to add to our armoury against COVID-19. It is also the world’s first approved antiviral for this disease that can be taken by mouth rather than administered intravenously. This is important because it means it can be administered outside of a hospital setting before COVID-19 has progressed to a severe stage.

“With no compromises on quality, safety and effectiveness, the public can trust that the MHRA has conducted a robust and thorough assessment of the data.”

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