USA – Pfizer, a US-based pharmaceutical giant has asked the Food and Drug Administration to approve its experimental COVID-19 pill for emergency use, setting the stage for a likely launch of the promising therapy in the coming weeks.
The treatment was shown in clinical trials to reduce the risk of hospitalization and death by 89 percent in people at high risk of severe illness.
Results of that trial, which was halted early after researchers reported the drug’s efficacy, showed that treatment reduced the risk of hospitalization or death from COVID-19 significantly when given soon after symptoms began.
An antiviral pill for Covid would have a significant impact on the coronavirus pandemic by making treatment available at home, without the need for injections or IVs.
In September, another study began using the antiviral treatment to prevent Covid in adults who live in the same household as someone with a confirmed symptomatic infection.
Pfizer’s treatment consists of three pills taken twice daily for five days. It is intended to be administered within three to five days of the onset of symptoms.
Pfizer’s pill, Paxlovid, is the second oral COVID-19 drug to be proven highly effective in large, placebo-controlled clinical trials, following Merck’s molnupiravir, which was approved by UK regulators in early November.
An FDA panel is scheduled to meet on November 30 to consider molnupiravir, an antiviral drug developed by Merck and Ridgeback Biotherapeutics.
In addition to the United States, Pfizer is seeking approval in the United Kingdom, Australia, New Zealand, and South Korea, with plans to file additional submissions in other countries.
Both treatments, which work in different ways to prevent the coronavirus from replicating. Pfizer’s drug is part of a decades-old class of antiviral drugs known as protease inhibitors, which revolutionized HIV and hepatitis C treatment.
The drugs inhibit a key enzyme required by viruses to multiply in the human body. This is in contrast to the Merck’s pill, which causes tiny mutations in the coronavirus to the point where it can no longer reproduce itself.
Pfizer said in a statement that the treatment is safe and that side effects were mild, occurring at the same rate as in the placebo group. It didn’t detail what the side effects were.
Generic pharma companies to make Pfizer’s pill
Meanwhile, Pfizer Inc has announced that it had signed a deal with a U.N.-backed group to allow other drug manufacturers to make the pill, which could make it available to more than half of the world’s population.
Pfizer said in a statement that it would license the antiviral pill to the Swiss-based Medicines Patent Pool, allowing generic drug companies to produce the pill for use in 95 countries, accounting for roughly 53% of the world’s population.
The agreement excludes several large countries that have experienced devastating coronavirus outbreaks. For example, a Brazilian pharmaceutical company could obtain a license to manufacture the pill for export to other countries, but the medicine could not be manufactured generically for use in Brazil.
Nonetheless, health officials have said that the fact that the agreement was reached before Pfizer’s pill was approved anywhere could help to end the pandemic sooner.
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