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Pfizer (PFE) Gets FDA's Emergency Use Nod for COVID Pill

Pfizer's (PFE) COVID-19 pill Paxlovid is the first oral antiviral medicine, which can be prescribed as an at-home treatment for mild-to-moderate COVID-19.

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This story originally appeared on Zacks

Pfizer PFE announced that the FDA has granted Emergency Use Authorization (EUA) to its promising oral antiviral candidate for COVID-19, Paxlovid, amid rising infection rates. The Omicron variant of the virus has been spreading rapidly across the United States.

- Zacks

Paxlovid has been authorized for use in combination with low-dose ritonavir to treat mild-to-moderate COVID-19 in adult and pediatric patients (12 years and older and weighing at least 40 kg) at increased risk of hospitalizations or death.

Paxlovid’s approval 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) 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.

Pfizer expects to begin delivering Paxlovid immediately. Last month, it signed an agreement with the U.S. government for the supply of 10 million treatment courses of Paxlovid. In exchange, the company will receive $5.29 billion from the U.S. government. The delivery of these treatment courses is expected to be completed in 2022.

Pfizer expects to manufacture 120 million courses of Paxlovid by the end of 2022. 

Paxlovid is the first oral antiviral medicine, which can be prescribed as an at-home treatment to help fight mild-to-moderate COVID-19 infection. It can help prevent hospitalization in patients with a mild-to-moderate form of the disease but at high risk of severe COVID-19 and thus lower some of the pressure facing the healthcare and hospital systems. Pfizer also plans to file a new drug application (NDA) with the FDA for full regulatory approval of Paxlovid in 2022. 

President Biden called Paxlovid a “promising new treatment option” that will lower rates of hospitalization and death in a statement issued after the FDA’s EUA. The statement also mentioned that 250,000 treatment courses of Paxlovid are expected to be supplied by Pfizer in January.

Pfizer’s stock has risen 67.6% this year so far compared with an increase of 22.7% for the industry.

Zacks Investment ResearchImage Source: Zacks Investment Research

As regards other countries, in Europe, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued an advice for Paxlovid. The advice stated that Paxlovid could be used for treating COVID-19 in adults who do not require supplemental oxygen and who are at increased risk of progressing to severe disease. The advice means authorities of European member states can allow supply and use of the oral pill in emergency situations even before EU’s conditional marketing authorization. The EMA is presently conducting a rolling review of the marketing application.

Pfizer has begun rolling submissions in several other countries including the United Kingdom, Australia, New Zealand and South Korea.

At present, mild-to-moderate COVID-19 patients are being treated with monoclonal antibodies from companies like Regeneron REGN and Eli Lilly LLY 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 is approved for treatment and post-exposure prophylaxis in certain high-risk individuals. It has become a significant contributor to its top line in recent quarters.

Regeneron is in discussions with the FDA to expand the current EUA to other populations, including pre-exposure prevention and hospitalized patient settings. Regeneron’s antibody cocktail was approved in Europe (known as Ronapreve in the European Union) last month for the treatment as well as prevention of COVID-19 in November.

Another large drugmaker, Merck MRK, has also made 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. In November, the FDA’s Antimicrobial Drugs Advisory Committee (AMDAC) voted 13-0 to recommend the authorization of molnupiravir to treat mild-to-moderate COVID-19 in at-risk adults. The FDA is expected to give its final decision soon.

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, in November.

Pfizer’s Paxlovid has however proved more effective than molnupiravir, which reduced the risk of hospitalization or death by approximately 30% in non-hospitalized at-risk adult patients with mild or moderate COVID-19, per final data from the MOVe-OUT phase III study. Nonetheless, both pills are being seen as crucial to fight the pandemic and reduce pressure on hospitals.

Importantly, Paxlovid and molnupiravir, are expected to work well against the Omicron variant, while most of the monoclonal antibody drugs appear to be largely ineffective against the same.

Pfizer currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.



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