Pfizer’s COVID-19 pill Paxlovid receives full FDA approval

USA — In a major development, Pfizer has obtained full approval from the U.S. Food and Drug Administration (FDA) for its groundbreaking COVID-19 pill, Paxlovid.

This oral antiviral treatment has emerged as a go-to option for combating the virus, showcasing significant efficacy in reducing hospitalizations and deaths associated with COVID-19.

While the benefits are predominantly observed in unvaccinated individuals and those at higher risk, Paxlovid has proven to be a valuable tool in the fight against the ongoing pandemic.

Unlike many other treatments that were introduced during the global health crisis, Paxlovid has demonstrated its potential to combat severe disease when administered within five days of symptom onset.

This crucial timeframe for early intervention has been instrumental in preventing the progression of COVID-19 in vulnerable patients.

The U.S. government plans to utilize its existing inventory of Paxlovid, which was procured from Pfizer, before transitioning to the commercial market.

Since its distribution began, Paxlovid has gained significant traction, with over 14 million treatment courses distributed and more than 9 million courses already administered, according to federal data as of May 21.

Initially granted emergency use authorization based on preliminary studies, the full approval now allows Pfizer’s groundbreaking drug to remain on the market indefinitely and be marketed similarly to other established pharmaceuticals.

The FDA’s full approval of Paxlovid primarily targets adults who face a high risk of severe COVID-19, including older adults and individuals with underlying medical conditions such as diabetes, asthma, and obesity.

This regulatory milestone is a significant achievement for Pfizer, as it solidifies the drug’s position in the market and ensures its availability for those in need.

Pfizer’s cash flow received a substantial boost from the sales of its COVID-19 vaccines and treatments. In 2021 alone, Paxlovid generated around US$18.9 billion in revenue, and the company projects sales of approximately US$8 billion for 2023.

The U.S. government has procured nearly 24 million courses of Paxlovid from Pfizer, with each course priced at around US$530.

Notably, the Institute for Clinical and Economic Review (ICER) recommended a price range of US$563 to US$906 per treatment course based on the drug’s benefits and value to patients.

While Paxlovid has received full FDA approval for adults, it remains available for children aged 12 to 17 under a separate emergency use authorization.

The U.S. government has stockpiled millions of doses of Paxlovid, and patients will continue to receive the treatment free of charge, according to the FDA.

This achievement marks a significant milestone, as Paxlovid is the first oral COVID-19 treatment to receive full FDA approval.

Previous therapies approved by the FDA were intravenous or injectable drugs typically administered in clinical or hospital settings.

Pfizer’s initial studies focused on the highest-risk COVID-19 patients, namely unvaccinated adults with underlying health conditions and no evidence of prior coronavirus infection.

In this group, Paxlovid demonstrated an impressive 86 percent reduction in the risk of hospitalization or death when administered promptly after the onset of symptoms.

It is important to note that the current U.S. population has a vaccination rate of over 95 percent, with many individuals also having prior infection immunity.

However, recent studies have shown that Paxlovid still significantly decreases the chances of hospitalization or death by more than 85 percent in people who have previously contracted COVID-19.

Safety concerns regarding a potential rebound in COVID-19 symptoms after a five-day Paxlovid course were addressed during an FDA advisory meeting.

Data presented by both Pfizer and the FDA helped alleviate these concerns, indicating that there is no clear association between the use of Paxlovid and the resurgence of COVID-19 symptoms.

The full approval of Paxlovid comes just two weeks after the U.S. ended the public health emergency status for COVID-19, which has tragically resulted in approximately 1.1 million deaths nationwide.

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