Pfizer Files for FDA Approval for Its COVID Pill

Pharmaceutical giant Pfizer said it filed for FDA approval for its COVID pill. High-risk patients can use this drug to treat coronavirus infections. Get the go-ahead for emergency use to make Pfizer’s new drug available to Americans by the end of the year. 

RELATED: FDA Issues Full Approval for Pfizer, BioNTech Vaccine

Emergency Use Authorization for Pfizer’s COVID Pill

Pfizer hopes to get an emergency use authorization for Paxlovid from the US Food and Drug Administration soon enough. An approval can provide relief to doctors, nurses, and medical centers overrun with more coronavirus cases than they could handle.

Taking the COVID pill can drastically reduce the chances of hospitalization and death among patients.  The recommended course for treatment is 30 pills for five days.

This regimen consists of taking two pills of Paxlovid daily plus one pill of ritonavir, another antiviral drug. 

According to Pfizer CEO Albert Bourla, Paxlovid represents an effective treatment. “There is an urgent need for life-saving treatment options. We are moving as quickly as possible in our effort to get this potential treatment into the hands of patients.”

Current Treatment Options For COVID Patients

Currently, health officials and medical practitioners have limited options to treat COVID-19. Once infection sets in, many doctors can only hope that patients will not require hospitalization or assistance in breathing.

Right now, many doctors are using Remdesivir, a Gilead Sciences treatment, to help cure hospitalized patients. A course of treatment can cost up to $3,100. 

Meanwhile, monoclonal antibody treatments also proved effective to slow down the virus. However, these treatments cost a lot of money and will require doctors’ approval. A two-drug cocktail usually costs $1,250 per infusion. 

Pfizer Can Only Manufacture 180,000 Courses This Year

Even with approval for Pfizer’s COVID pill this year, initial supplies will remain limited. The company projects it can only manufacture 180,000 treatment courses until year-end.

By next year, however, it can boost production to at least 50 million courses. However, these numbers still won’t likely meet global demand for 2022.

As many as 150 million adults worldwide will need Paxlovid to treat their COVID infections. 

Meanwhile, the US moved early to get a lock on early available stocks. Prior to any FDA approvals, President Joe Biden announced that the US secured a deal with Pfizer to provide supplies once they get authorization. The initial contract covers 10 million treatment courses. 

Pfizer To Waive Profits In Some Lower-Earning Countries

On Tuesday, Pfizer also said that it plans to license Paxlovid to the Medicines Patent Pool. This is a United Nations initiative to expand medicine access to 95 low and middle-income countries.

It also plans to partner with generic drug manufacturers to churn out more COVID treatments in pill form. This also hopes to reduce prices and make Paxlovid more available. MPP Executive Director Charles Gore said that “We want to make absolutely certain that there is enough supply.”

Pfizer to Waive Royalties In the First Three Months of 2002

In addition, the drugmaker said that they forego royalties in lower-income countries. Pfizer said that it would also waive royalties for other countries covered by the agreement, at least for the next three months.

Afterward, the company will start collecting royalties of 5% from government sales and 10% from private sales. Outside of Pfizer’s COVID-19, Merck also applied for approval for its trademark, Molnupiravir. 

This drug is currently undergoing similar trials and favorable results within the next year.

Watch the CNBC Television video reporting that Pfizer submits Covid antiviral pill for EUA:

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