The FDA’s Antimicrobial Drugs Advisory Committee (AMDAC) voted in favor of authorizing
Merck ( MRK Quick Quote MRK - Free Report) and partner Ridgeback Biotherapeutics’ oral antiviral medicine, molnupiravir.
Merck filed an application with the FDA last month seeking Emergency Use Authorization (EUA) for molnupiravir to treat mild-to-moderate COVID-19 in patients who are at high risk of progressing to severe COVID-19 and/or hospitalization.
Regarding this EUA, the AMDAC voted 13-0 that the medicine’s potential benefits outweigh its risks for treating mild-to-moderate COVID-19 in at-risk adults who are within five days of symptom onset. A few panel members, however, had concerns about the use of the drug in pregnant women. The FDA is expected to give its final decision this year. Though the FDA is not bound by the committee’s recommendation, it usually follows the same.
Merck’s shares were up a little more than 2% in response to the FDA panel’s backing for its antiviral pill. Merck’s stock has declined 7.5% this year so far against an increase of 12.9% for the
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Merck’s EUA application was based on positive data from the interim analysis of the phase III MOVe-OUT study. Earlier this week, Merck announced final data from the MOVe-OUT study, which showed that molnupiravir reduced the risk of hospitalization or death by approximately 30% in non-hospitalized at-risk adult patients with mild or moderate COVID-19, which was less than 50% as previously reported, per interim data announced in October. Shares of Merck declined as the final data showed the pill was less effective than previously reported. The additional data was also shared with the FDA and was reviewed by the AMDAC.
In Europe, the European Medicines Agency has begun a rolling review of Merck/Ridgeback Biotherapeutics’ regulatory application for molnupiravir. Molnupiravir was authorized in the United Kingdom (branded as Lagevrio), its first authorization in the world, earlier this month for treating mild-to-moderate COVID-19 patients at risk of progressing to severe illness.
Merck expects to produce 10 million courses of molnupiravir by the end of 2021 and believes the treatment’s global opportunity to be approximately $5 billion to $7 billion through 2022, including $0.5 billion to $1 billion expected to be realized in 2021.
Pfizer ( PFE Quick Quote PFE - Free Report) has also made an oral antiviral candidate, Paxlovid, for COVID-19. Pfizer filed an application with the FDA earlier this month, seeking EUA for Paxlovid for the treatment of mild-to-moderate COVID-19 in patients at increased risk of hospitalizations or death.
In clinical studies, Paxlovid reduced the risk of hospitalization or death by 89% compared to placebo in an interim analysis of phase II/III study. Pfizer has also begun rolling submissions in several 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 Pharmaceuticals ( REGN Quick Quote REGN - Free Report) and Eli Lilly ( LLY Quick Quote LLY - Free Report) . But these need to be administered in a hospital intravenously or by subcutaneous infusion.
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 based on data from the BLAZE-1 study.
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 recent quarters. Regeneron’s antibody cocktail, REGEN-COV, generated total sales of $1.2 billion in the third quarter of 2021.
With the risk of infection rising due to the threat posed by the rapidly spreading and highly contagious Omicron variant, the need for new treatments and vaccines has increased. If authorized by the FDA, Paxlovid and molnupiravir can be the first oral antiviral medicines 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.
Merck currently carries a Zacks Rank #3 (Hold). You can see
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