The U.K.’s drugs regulator on Friday approved the use of a second oral COVID-19 pill to be taken at home.
The Medicines and Healthcare Products Regulatory Agency (MHRA) said Pfizer’s Paxlovid can be given to people aged 18 and older with mild to moderate symptoms and who are at risk of developing severe disease. This includes people with obesity, diabetes or heart disease, or those over 60.
In a clinical trial in this patient group, Paxlovid, which is a combination of two pills, reduced the risk of hospitalization or death by 89 percent compared with those given a placebo.
For those who are particularly vulnerable to COVID-19, “this treatment could be life-saving,” said June Raine, chief executive of the MHRA.
The Omicron coronavirus variant rapidly surging across the country has squeezed the availability of effective treatment options. The variant has mutations that can dodge the protective effects of Roche/Regeneron’s monoclonal antibody Ronapreve, which has been used for some time in the U.K.
Scientists believe that antivirals, which attack a different part of the virus preventing it from replicating, are more likely to remain effective against Omicron. Research in this area is ongoing.
Paxlovid is the second oral antiviral to be conditionally approved for use in the U.K. recently, after MSD/Ridgeback’s molnupiravir, also known as Lagevrio, was also authorized on November 4. Both are used to treat people at home and both medicines must be given within five days of symptoms.
Gilead’s remdesivir is another antiviral to treat COVID-19, but this requires intravenous administration.
The U.K.’s Antiviral Taskforce has signed a deal for 2.23 million treatment courses with Lagevrio and 2.75 million regimens of Paxlovid.
The task force has launched a real-world study of molnupiravir, also known as Lagevroio, to understand its efficacy in a highly vaccinated population. This antiviral demonstrated around 30 percent reduced risk of hospitalization or death versus a placebo in at-risk people.
The PANORAMIC study will most likely be adjusted to include Paxlovid once it is approved, trial investigators told journalists recently. The government and the NHS will confirm how this COVID-19 treatment will be given to patients in due course, the MHRA said.
In Europe, the European Medicines Agency provided guidance on the use of both Pfizer and MSD’s antivirals for use in an emergency.
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