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Pfizer's (PFE) COVID-19 Drug Paxlovid Gets FDA Panel Vote

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Pfizer, Inc. (PFE - Free Report) announced that the FDA’s Antimicrobial Drugs Advisory Committee (AMDAC) voted 16 to 1 in favor of Paxlovid for the treatment of mild-to-moderate COVID-19 in adult patients who are at high risk for progression to severe illness. Paxlovid is Pfizer’s nirmatrelvir tablets and ritonavir tablets. This vote signifies that the AMDAC believes that the available data on Paxlovid supports its safety and efficacy to treat the aforementioned indication. It is to be noted that the AMDAC’s vote is not binding, but will be taken into consideration by the FDA in deciding whether to grant full approval to Paxlovid.

We would like to remind the investors that the FDA granted emergency use authorization (EUA) to Paxlovid in December 2021 and has since witnessed more than 10 million treatment courses, prescribed in the United States.

In the past year, the shares of Pfizer have plunged 25.6% against the industry’s rise of 0.7%.

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The AMDAC vote was based on all the scientific data and the real-world evidence presented by Pfizer. This included safety and efficacy data from its phase II/III EPIC-HR study of Paxlovid in unvaccinated, non-hospitalized adults aged 18 years and older with confirmed COVID-19, who are at high risk (moderate to severe) of hospitalization or death. The study met its primary endpoint witnessing an 86% reduction in risk of COVID-19-related hospitalization or death from any cause through Day 28 in patients treated with Paxlovid within five days of symptoms onset compared with placebo.

Real-world evidence presented to the AMDAC demonstrated that the clinical profile of Paxlovid post its EUA was consistent with the safety and efficacy conclusions drawn from the company’s EPIC studies.

COVID-19 continues to affect people in the United States as case rates fluctuate and new variants and sub-variants emerge, regardless of virulence. As of January 2023, approximately 4,000-5,000 hospital admissions and 500-600 deaths were caused by the virus each day in the United States. More than 200 million adults in the United States are at high risk of severe COVID-19. This highlights a clear unmet medical need for treatment options.

The FDA is expected to announce its decision in May 2023 regarding the full approval of Paxlovid. Currently, it is authorized for use in and remains available to adults and pediatric patients (12 years of age and older weighing at least 40 kg) at high risk of progression to severe COVID-19. Subject to approval, Paxlovid has the potential to become the first FDA-approved oral treatment for COVID-19.

Pfizer is currently studying Paxlovid in an ongoing EPIC-Peds study to potentially expand its label to treat pediatric patients and expects to submit a supplemental new drug application to the FDA on a future date. Pfizer received marketing authorization for Paxlovid to treatfor the treatment of certain adults who have been diagnosed with COVID-19 in the European Union (EU) from the European Commission in February 2023. 

Merck (MRK - Free Report) also launched an oral antiviral, molnupiravir which received a EUA from the FDA, in December 2021, to treat mild-to-moderate COVID-19 in adults with confirmed COVID-19 aged 18 and older, at high risk for progression to severe COVID-19, including hospitalization or death. Merck claimed that more than 4 million patients worldwide have been treated with Lagevrio (molnupiravir), playing an important role in the COVID-19 treatment landscape. Merck, along with partner Ridgeback, also recently announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended the refusal of the marketing authorization for Lagevrio for the treatment of certain adults who have been diagnosed with COVID-19 in the EU. Following the CHMP opinion, Merck and Ridgeback are set to appeal the decision based on its phase III MOVe-OUT study evaluating the safety and efficacy of Lagevrio.

In a separate press release, Pfizer and partner, Astellas Pharma, announced positive top-line data from its phase III EMBARK study evaluating Xtandi (enzalutamide) in men with non-metastatic hormone-sensitive prostate cancer with high-risk biochemical recurrence. Patients in the study were given either of the three combinations, Xtandi plus leuprolide, placebo plus leuprolide and Xtandi monotherapy. The companies reported that the study met its primary endpoint with statistical significance and showed clinically meaningful improvement in metastasis-free survival (MFS) for patients treated with Xtandi plus leuprolide versus placebo plus leuprolide.

Additionally, the study met a key secondary endpoint with a statistically significant and clinically meaningful improvement in MFS for patients treated with XTANDI monotherapy versus placebo plus leuprolide. A positive trend in the overall survival rate was also observed, although the companies claim that the data is not yet mature. Several other secondary endpoints are currently being analyzed by the companies and the safety profile of Xtandi has remained constant according to past data. The company intends to conduct discussions with regulatory bodies, including the FDA, to support a potential regulatory submission for Xtandi in this indication.

Pfizer Inc. Price and Consensus

Pfizer Inc. Price and Consensus

Pfizer Inc. price-consensus-chart | Pfizer Inc. Quote

Zacks Rank and Stocks to Consider

Pfizer currently carries a Zacks Rank #5 (Strong Sell).

Some top-ranked stocks in the overall healthcare sector are Novo Nordisk (NVO - Free Report) , which sports a Zacks Rank #1 (Strong Buy) and Avalo Therapeutics (AVTX - Free Report) , carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 90 days, estimates for Novo Nordisk’s 2023 earnings per share have risen from $4.03 to $4.43. Shares of Novo Nordisk have risen 24.6% in the past year.

NVO beat earnings estimates in three of the last four quarters while missing the mark on one occasion, witnessing an earnings surprise of 3.00%, on average.

In the last 90 days, Avalo’s loss estimates for the year 2023 have narrowed from $3.62 to $2.57 per share. In the past year, the shares of Avalo have plunged 70.5%.

AVTX beat earnings estimates in two of the last three reported quarters, missing the mark on one occasion, delivering an average earnings surprise of 37.83%.

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