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Pfizer (PFE) Seeks FDA's Emergency Use Nod for COVID Pill
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Pfizer (PFE - Free Report) announced that it has filed an application to the FDA seeking Emergency Use Authorization (EUA) for its promising oral antiviral candidate for COVID-19, Paxlovid for the treatment of mild-to-moderate COVID-19 in patients at increased risk of hospitalizations or death
Pfizer’s regulatory application was based on clinical data from an interim analysis of a phase II/III study, EPIC-HR study. Data from the study showed that Paxlovid (administered in combination with low dose ritonavir) reduced the risk of hospitalization or death by 89% in non-hospitalized adult patients with COVID-19 at high risk of progressing to severe illness compared to placebo within three days of symptom onset. Similar benefits were observed in patients treated within five days of symptom onset.
At the recommendation of an independent Data Monitoring Committee, Pfizer stopped the study early due to the high efficacy observed in the interim analysis. Pfizer has begun rolling submissions in several countries including the United Kingdom, Australia, New Zealand and South Korea.
In a separate press release, Pfizer announced that it has signed a voluntary licensing agreement with The Medicines Patent Pool (MPP), a United Nations-backed public health organization, to facilitate affordable global access for Paxlovid in 95 low- and middle-income countries (LMICs) upon local regulatory authorization or approval.
Pfizer’s stock has risen 34.8% this year so far compared with an increase of 16.1% for the industry.
Image Source: Zacks Investment Research
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.
Lilly’s COVID-19 antibody cocktail, bamlanivimab plus etesevimab, was granted emergency approval by the FDA in February 2021 to treat mild-to-moderate COVID-19 in high-risk patients.
In September, the FDA expanded the EUA for the cocktail antibody medicine to include the post-exposure prevention (prophylaxis) for COVID-19 indication. Lilly’s cocktail medicine generated revenues of $217.1 million in the third quarter of 2021.
Regeneron’s antibody cocktail, REGEN-COV comprises two monoclonal antibodies, casirivimab and imdevimab and has become a significant contributor to its top line in the recent quarters. Regeneron is in discussions with the FDA to expand the current EUA to other populations, including prevention and hospitalized patient settings.
Another large drugmaker, Merck (MRK - Free Report) , is also making an oral antiviral pill, molnupiravir, for treating non-hospitalized COVID-19 patients. 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.
Meanwhile, in Europe, the European Medicines Agency has begun a rolling review of Merck and Ridgeback Biotherapeutics’ regulatory application for molnupiravir. Molnupiravir was authorized in the United Kingdom, its first authorization in the world, earlier this month for the treatment of patients with mild-to-moderate COVID-19 patients at risk of progressing to severe illness.
If approved by the FDA, Paxlovid and molnupiravir can be the first oral antiviral medicines, which can be prescribed as at-home treatments 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.
Image: Bigstock
Pfizer (PFE) Seeks FDA's Emergency Use Nod for COVID Pill
Pfizer (PFE - Free Report) announced that it has filed an application to the FDA seeking Emergency Use Authorization (EUA) for its promising oral antiviral candidate for COVID-19, Paxlovid for the treatment of mild-to-moderate COVID-19 in patients at increased risk of hospitalizations or death
Pfizer’s regulatory application was based on clinical data from an interim analysis of a phase II/III study, EPIC-HR study. Data from the study showed that Paxlovid (administered in combination with low dose ritonavir) reduced the risk of hospitalization or death by 89% in non-hospitalized adult patients with COVID-19 at high risk of progressing to severe illness compared to placebo within three days of symptom onset. Similar benefits were observed in patients treated within five days of symptom onset.
At the recommendation of an independent Data Monitoring Committee, Pfizer stopped the study early due to the high efficacy observed in the interim analysis. Pfizer has begun rolling submissions in several countries including the United Kingdom, Australia, New Zealand and South Korea.
In a separate press release, Pfizer announced that it has signed a voluntary licensing agreement with The Medicines Patent Pool (MPP), a United Nations-backed public health organization, to facilitate affordable global access for Paxlovid in 95 low- and middle-income countries (LMICs) upon local regulatory authorization or approval.
Pfizer’s stock has risen 34.8% this year so far compared with an increase of 16.1% for the industry.
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.
Lilly’s COVID-19 antibody cocktail, bamlanivimab plus etesevimab, was granted emergency approval by the FDA in February 2021 to treat mild-to-moderate COVID-19 in high-risk patients.
In September, the FDA expanded the EUA for the cocktail antibody medicine to include the post-exposure prevention (prophylaxis) for COVID-19 indication. Lilly’s cocktail medicine generated revenues of $217.1 million in the third quarter of 2021.
Regeneron’s antibody cocktail, REGEN-COV comprises two monoclonal antibodies, casirivimab and imdevimab and has become a significant contributor to its top line in the recent quarters. Regeneron is in discussions with the FDA to expand the current EUA to other populations, including prevention and hospitalized patient settings.
Another large drugmaker, Merck (MRK - Free Report) , is also making an oral antiviral pill, molnupiravir, for treating non-hospitalized COVID-19 patients. 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.
Meanwhile, in Europe, the European Medicines Agency has begun a rolling review of Merck and Ridgeback Biotherapeutics’ regulatory application for molnupiravir. Molnupiravir was authorized in the United Kingdom, its first authorization in the world, earlier this month for the treatment of patients with mild-to-moderate COVID-19 patients at risk of progressing to severe illness.
If approved by the FDA, Paxlovid and molnupiravir can be the first oral antiviral medicines, which can be prescribed as at-home treatments 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 currently has a Zacks Rank #3 (Hold).You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.