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Pfizer’s (PFE - Free Report) oral antiviral candidate for COVID-19, Paxlovid reduced the risk of hospitalization or death by 89% compared to placebo in an interim analysis of a phase II/III study.
The study, EPIC-HR, was conducted on non-hospitalized adult patients with COVID-19 who were at high risk of progressing to severe illness. The data showed that 0.8% of the patients treated with Paxlovid within three days of symptom onset were hospitalized and no one died through Day 28 following randomization compared to 7% of the patients in the placebo arm who were hospitalized or died. Similarly, in patients treated within five days of symptom onset, 1% of those treated with Paxlovid were hospitalized through Day 28 following randomization compared to 6.7% of the patients in the placebo arm.
At the recommendation of an independent Data Monitoring Committee, Pfizer stopped the study early due to the high efficacy observed in the interim analysis. It plans to submit this data as part of a rolling submission to the FDA for seeking Emergency Use Authorization (EUA) for the oral antiviral drug.
At present, mild-to-moderate COVID-19 patients are being treated with monoclonal antibodies from companies like Regeneron Pharmaceuticals (REGN - Free Report) and Eli Lilly (LLY - Free Report) but they need to be administered in a hospital. If approved by the FDA, Paxlovid would be the first such oral antiviral medicine, which can be prescribed as an at-home treatment for mild-to-moderate COVID-19 to reduce the severity of the disease. It can help prevent hospitalization in patients with a mild-to-moderate form of the disease but at high risk of severe COVID-19.
Pfizer’s shares were up almost 11% on Friday in response to the high efficacy of the COVID pill in the study. Pfizer’s stock has risen 32.1% this year so far compared with an increase of 16.6% for the industry.
However, shares of another large drugmaker, Merck (MRK - Free Report) , which is also making an oral antiviral pill, molnupiravir, for treating non-hospitalized COVID-19 patients, were down almost 10% on Friday. Merck along with partner Ridgeback Biotherapeutics has already filed an application seeking EUA for molnupiravir. The application was based on positive data from the interim analysis of the phase III MOVe-OUT study, which showed that the medicine reduced the risk of hospitalization or death by approximately 50% in non-hospitalized adult patients with mild or moderate COVID-19. Molnupiravir was granted its first authorization in the United Kingdom last week under the brand name of Lagevrio.
Image: Bigstock
Pfizer (PFE) COVID Pill Shows Strong Efficacy, Stock Rallies
Pfizer’s (PFE - Free Report) oral antiviral candidate for COVID-19, Paxlovid reduced the risk of hospitalization or death by 89% compared to placebo in an interim analysis of a phase II/III study.
The study, EPIC-HR, was conducted on non-hospitalized adult patients with COVID-19 who were at high risk of progressing to severe illness. The data showed that 0.8% of the patients treated with Paxlovid within three days of symptom onset were hospitalized and no one died through Day 28 following randomization compared to 7% of the patients in the placebo arm who were hospitalized or died. Similarly, in patients treated within five days of symptom onset, 1% of those treated with Paxlovid were hospitalized through Day 28 following randomization compared to 6.7% of the patients in the placebo arm.
At the recommendation of an independent Data Monitoring Committee, Pfizer stopped the study early due to the high efficacy observed in the interim analysis. It plans to submit this data as part of a rolling submission to the FDA for seeking Emergency Use Authorization (EUA) for the oral antiviral drug.
At present, mild-to-moderate COVID-19 patients are being treated with monoclonal antibodies from companies like Regeneron Pharmaceuticals (REGN - Free Report) and Eli Lilly (LLY - Free Report) but they need to be administered in a hospital. If approved by the FDA, Paxlovid would be the first such oral antiviral medicine, which can be prescribed as an at-home treatment for mild-to-moderate COVID-19 to reduce the severity of the disease. It can help prevent hospitalization in patients with a mild-to-moderate form of the disease but at high risk of severe COVID-19.
Pfizer’s shares were up almost 11% on Friday in response to the high efficacy of the COVID pill in the study. Pfizer’s stock has risen 32.1% this year so far compared with an increase of 16.6% for the industry.
However, shares of another large drugmaker, Merck (MRK - Free Report) , which is also making an oral antiviral pill, molnupiravir, for treating non-hospitalized COVID-19 patients, were down almost 10% on Friday. Merck along with partner Ridgeback Biotherapeutics has already filed an application seeking EUA for molnupiravir. The application was based on positive data from the interim analysis of the phase III MOVe-OUT study, which showed that the medicine reduced the risk of hospitalization or death by approximately 50% in non-hospitalized adult patients with mild or moderate COVID-19. Molnupiravir was granted its first authorization in the United Kingdom last week under the brand name of Lagevrio.
Pfizer currently has a Zacks Rank #3 (Hold).You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.