Pfizer’s PAXLOVID Bags Emergency Use Approval by the FDA

Pfizer’s (NYSE: PFE) COVID-19 oral antiviral treatment, PAXLOVID, has received authorization for emergency use from the U.S. Food and Drug Administration (FDA) for people aged 12 and older and weighing at least 40 kg.

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PAXLOVID (nirmatrelvir tablets and ritonavir tablets) is designed to treat mild-to-moderate COVID-19 in adults and pediatric patients, with positive results of direct SARS-CoV-2 viral testing. These patients also include individuals at high risk for progression to severe COVID-19, including hospitalization or death.

Supporting Data

The regulator’s approval followed clinical data from a Phase 2/3 EPIC-HR (Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients) trial. Results demonstrated that PAXLOVID reduced the risk of hospitalization or death by 89% (within three days of symptom onset) and 88% (within five days of symptom onset) compared to placebo.

Future Actions

Following the emergency use authorization (EUA) for PAXLOVID, Pfizer is ready to begin delivery in the U.S. immediately. Notably, in November 2021, Pfizer inked a deal with the U.S. government to supply 10 million treatment courses of PAXLOVID by 2022.

With continuous efforts and investments to support the manufacturing and distribution of PAXLOVID, Pfizer estimates production of 120 million courses of treatment by the end of 2022, up from prior expectations of 80 million.

Approvals

Along with the FDA EUA, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recently recommended PAXLOVID to treat adults with COVID-19 who do not require supplemental oxygen and are at increased risk of progressing to severe disease.

Notably, Pfizer expects authorizations from other global regulatory agencies as well. Additionally, the company has planned to file a New Drug Application (NDA) for full regulatory approval with the FDA in 2022.

CEO Comments

Pfizer CEO Albert Bourla said, “Today’s authorization of PAXLOVID represents another tremendous example of how science will help us ultimately defeat this pandemic, which, even two years in, continues to disrupt and devastate lives across the world. This breakthrough therapy, which has been shown to significantly reduce hospitalizations and deaths and can be taken at home, will change the way we treat COVID-19, and hopefully help reduce some of the significant pressures facing our healthcare and hospital systems.”

“Pfizer stands ready to begin delivery in the U.S. immediately to help get PAXLOVID into the hands of appropriate patients as quickly as possible,” Bourla added.

Analysts Recommendation

Following the recent update, Vamil Divan, an analyst from one of the Top Research Firms, Mizuho Securities, maintained a Hold rating and a price target of $56 (6% downside potential) on the stock.

Divan said, “We believe the authorization was widely expected given the impressive interim and final data from the EPIC-HR trial, and the timing is also in line with expectations of an EUA by year-end.”

The rest of the Street is cautiously optimistic about the stock, with a Moderate Buy consensus rating based on 7 Buys and 11 Holds. The average Pfizer price target of $56.12 implies 5.76% downside potential from current levels. Shares have increased 59.1% over the past year.

Risk Analysis

According to the new TipRanks Risk Factors tool, Pfizer stock is at risk mainly from three factors: Tech and Innovation, Ability to Sell, and Macro & Political, which contribute 25%, 25%, and 17%, respectively to the total 24 risks identified for the stock.