Pfizer Files for COVID-19 Antiviral Pill Emergency Use Approval; Will FDA Approve It?

Pfizer applied to the US Food and Drug Administration (FDA) for an emergency use authorization (EUA) of Paxlovid, an investigational Covid-19 antiviral therapy, on Tuesday.

According to the Agence France-Presse (via News.com.au), the medication reduced the likelihood of hospitalization and death in those at high risk of severe disease by 89 percent in clinical studies. However, the whole data hasn't been made available for scientists to analyze.

The tablet will be used in conjunction with an earlier antiviral medicine called ritonavir to treat mild to moderate Covid-19 patients at a higher risk of hospitalization or death.

Pfizer Seeking Emergency Use in US

Pfizer had offered its application for Paxlovid's emergency use authorization (EUA) to the US Food and Drug Administration.

It's unclear when US authorities will decide on Pfizer's application.

Merck & Co. and Ridgeback Biotherapeutics, which are creating molnupiravir, a rival pill, submitted their EUA on October 11.

On November 30, an FDA panel of independent advisors will meet to discuss the application. It is expected to be released in the United States this year.

"We are moving as quickly as possible in our effort to get this potential treatment into the hands of patients," Pfizer chief executive Albert Bourla said in a news release.

Molnupiravir, the first oral antiviral to be approved for the treatment of Covid-19, received approval from the UK Medicines and Healthcare Products Regulatory Agency earlier this month.

Pfizer Allows Other Companies Make Its COVID-19 Pill

Pfizer stated earlier Tuesday via NBC News that it had reached an agreement with a United Nations-backed initiative to allow other pharma companies to produce the tablet, potentially allowing it to reach more than half of the world's population.

Pfizer announced that the Geneva-based Medicines Patent Pool would be granted a license for the antiviral medication.

As a result, generic medicine companies will manufacture the tablet for usage in 95 nations, encompassing around 53 percent of the world's population.

The investigational tablet, which may be given orally as an early at-home therapy to help minimize COVID-19 hospitalizations and fatalities, could be a potential new weapon in the battle against the pandemic.

It reduced the likelihood of hospitalization or death for persons at risk of severe illness by 89 percent in a clinical study obtained by Science Times.

It might also be a useful tool in nations and locations where vaccines are scarce or immunization rates are low.

Some nations that have had disastrous coronavirus epidemics are excluded from the multi-nation agreement.

For example, while a Brazilian pharmaceutical business can get a license to manufacture a pill for export, manufacturers cannot produce the medicine generically for use in Brazil.

Nonetheless, health experts believe that the agreement was reached before Pfizer's pill was approved anywhere, which might assist in speeding up the end of the pandemic.