Pfizer Asks FDA to Authorize COVID-Fighting Pill It Says Cut Serious Cases By 89 Percent
Pfizer is asking the U.S. Food and Drug Administration (FDA) to approve its new COVID-19 treatment pill that it said decreased hospitalizations and deaths among high-risk adults by 89 percent, the Associated Press reported. The pharmaceutical company's request came as new virus cases are again beginning to rise and the colder weather forces more Americans to stay indoors.
Pfizer's pill is one of a few treatments that have recently emerged which aim to curb hospitalizations and fatalities as the pandemic approaches its second anniversary. The approval and launch of a treatment that reduces infection severity and potentially lets patients easily treat themselves at home could be key in the journey back to normalcy, the AP reported.
"We are moving as quickly as possible in our effort to get this potential treatment into the hands of patients, and we look forward to working with the U.S. FDA on its review of our application," said Albert Bourla, Pfizer's CEO, in a statement.
The company conducted trials with unvaccinated people who were high-risk, due to age or health issues, who were showing early symptoms of COVID-19 infection. Pfizer says that patients need to start taking the pills within three days of symptoms emerging, which could pose a challenge for those who don't have access to speedy testing.
If the FDA authorizes the treatment, it will also have to decide whether vaccinated people suffering from breakthrough infections should be able to take the pills, according to the AP.
For more reporting from the Associated Press, see below.
All FDA authorized treatments against COVID-19 require an IV or injection given by a health professional at a hospital or clinic.
FDA regulators will scrutinize company data on the safety and effectiveness of the drug, which will be sold as Paxlovid, before making a decision.
The FDA is holding a public meeting later this month where outside experts will scrutinize a competing drug from Merck, before voting on whether to recommend approval. The FDA isn't required to convene such meetings and it's not yet known whether Pfizer's drug will undergo a similar public review.
Some experts predict various COVID-19 therapies eventually will be prescribed in combination to better protect against the worst effects of the virus.
Several smaller drugmakers are also expected to seek authorization for their own antiviral pills in the coming months.
Pfizer's drug is part of a decades-old family of antiviral drugs known as protease inhibitors, which revolutionized the treatment of HIV and hepatitis C. The drugs block a key enzyme that viruses need to multiply in the human body. That's different than the Merck pill, which causes tiny mutations in the coronavirus until the point that it can't reproduce itself.
On Tuesday, Pfizer signed a deal a with U.N.-backed group to allow generic drugmakers to produce low-cost versions of the drug for use in 95 countries, a move that could make the treatment available in more than half of the world's population.
The U.S. has approved one other antiviral drug for COVID-19, remdesivir, and authorized three antibody therapies that help the immune system fight the virus. But they usually have to be given via time-consuming infusions at hospitals or clinics, and limited supplies were strained by the last surge of the Delta variant.
