UK approves Pfizer’s COVID-19 antiviral Paxlovid – POLITICO

The UK’s Medicines Regulatory Authority on Friday approved the use of an oral COVID-19 pill to be taken at home.

The Medicines and Healthcare products Regulatory Agency (MHRA) says Pfizer’s Paxlovid can be given to people 18 years of age or older who have mild to moderate symptoms and are at risk of serious illness. This includes people who are obese, have diabetes, have heart disease, or are over 60 years old.

In a clinical trial in this group of patients, Paxlovid, a combination of two pills, reduced the risk of hospitalization or death by 89% compared to those treated with a placebo.

For those particularly susceptible to COVID-19, “this treatment can be lifesaving,” said John Ryan, CEO of the MHRA.

The rapidly spreading coronavirus omicron variant across the country has reduced the availability of effective treatment options. The variant contains mutations that can evade the protective effects of the monoclonal antibody Roche/Regeneron Ronapreve, which has been used for some time in the UK.

Scientists believe that antivirals, which attack a different part of the virus preventing it from reproducing, are likely to remain effective against Omicron. Research in this field is ongoing.

Baxlovid is the second oral antiviral to have been conditionally approved for use in the UK recently, after MSD/Ridgeback’s molnupiravir, also known as Lagevrio, was licensed on 4 November. Five days of symptoms.

Gilead’s Remdesivir is another antiviral to treat COVID-19, but this requires intravenous administration.

The UK Antiviral Task Force has signed a deal for 2.23 million treatment cycles with Lagevrio and 2.75 million regimens from Paxlovid.

The task force launched a real-world study of molnopiravir, also known as Lagevroio, to understand its efficacy in a highly vaccinated population. This antiviral showed a 30 percent lower risk of hospitalization or death versus placebo in those at risk.

Trial investigators recently told reporters that the panoramic study will likely be modified to include baxlovids once it is approved. The government and the NHS will confirm how this COVID-19 treatment will be given to patients in a timely manner, the Department of Human Health and Medicine said.

In Europe, the European Medicines Agency has provided guidance on the use of Pfizer and MSD antivirals for emergency use.

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