BMJ op-ed calls molnupiravir authorization ‘premature’ 

Image courtesy of Merck & Co.

A recent editorial in the British Medical Journal (BMJ) criticized the decisions of British and U.S. health regulators to authorize the use of the antiviral molnupiravir, the COVID-19 antiviral.

The developers of the drug, Merck & Co. (NYSE:MRK) and Ridgeback Biotherapeutics, had announced that molnupiravir lowered the risk of hospital admissions or death by roughly 50% in the 29 days following infection with COVID-19.

WHO recently updated its treatment guidelines to include the drug for high-risk individuals. The organization based its decision on new data from six randomized controlled studies involving 4,796 patients.

Authorizations of molnupiravir will “inhibit further necessary evaluations” and could divert funding from more effective treatments, argued author James M Brophy, a professor of medicine and epidemiology at McGill University Health Center.<…

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Molnupiravir holds up to omicron in lab studies

Merck & Co. (NYSE:MRK) and its partner Ridgeback Biotherapeutics have shared data from six preclinical studies showing that the COVID-19 pill molnupiravir was active against the omicron variant in vitro.

The two companies continue to seek regulatory authorization for the drug internationally, which is currently authorized in more than 10 countries, including the U.S., the UK, Taiwan, Japan, India and Australia.

“Based on its mechanism of action, along with these new findings demonstrating in vitro activity across multiple variants, including omicron, we anticipate that molnupiravir will continue to be active against variants of concern and an important tool in the fight against COVID-19,” said Wendy Holman, Ridgeback Biotherapeutics CEO, in a statement. “We are grateful for the efforts of the investigators and look forward to continuing our work to help address the pandemic.”

The recent lab studies were conducted by independent researchers using cell…

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COVID-19 oral antiviral molnupiravir wins FDA nod

Merck (NYSE: MRK) and its partner Ridgeback Biotherapeutics have won emergency use authorization from FDA for the investigational oral antiviral molnupiravir (MK-4482, EIDD-2801). 

In late November, an FDA advisory panel narrowly voted in favor of authorizing molnupiravir. 

FDA recently also granted emergency use authorization to Pfizer’s (NYSE:PFE) oral SARS-CoV-2 antiviral Paxlovid (nirmatrelvir and ritonavir). 

FDA’s authorization of molnupiravir covers its use to treat mild-to-moderate COVID-19 in individuals at least 18 “who are at high-risk for progression to severe COVID-19.” The authorization constrains the use of the drug to individuals who cannot feasibly use other authorized COVID-19 treatments. FDA does not recommend the medication for patients who are hospitalized with COVID-19. 

The authorization does not support the use of molnupiravir as pre-exposure or post-exposure prophylaxis for COVID-19.

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FDA advisory committee votes in favor of COVID-19 pill molnupiravir

FDA’s Antimicrobial Drugs Advisory Committee narrowly concluded that the benefits of Merck’s (NYSE:MRK) COVID-19 pill molnupiravir outweigh the risks.

A total of 13 members of the panel voted in favor of the drug candidate, while 10 voted against it. There were no abstentions.

FDA generally follows the advice of its advisory committees.

“This was clearly a very difficult decision,” said Dr. Michael D. Green, a member of the advisory committee and professor at the University of Pittsburgh School of Medicine. “I would use it in high-risk non-vaccinated individuals,” Green said, adding he would consider the drug for people with obesity and multiple other risk factors. “For pregnancy, I would only use it if there’s no alternative therapy available, and I don’t think I would use it in the first trimester.”

Committee members who voted ‘no’ voiced several concerns.

Dr. Timothy Burgess of the Uniformed Services University cited the unconvincing cli…

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FDA advisory panel to weigh in on molnupiravir

An FDA advisory panel will consider whether emergency use authorization for Merck’s (NYSE:MRK) molnupiravir is warranted. The drug would be the first oral antiviral for COVID-19.

Although the conclusions of the Antimicrobial Drugs Advisory Committee are not binding, FDA generally follows its recommendations.

The benefit-risk calculation for molnupiravir has grown more complicated recently.

Over the Thanksgiving holiday, Merck announced that the drug offered a relative risk reduction of 50% against hospitalization or death. An earlier interim analysis of the Phase 2/3 MOVe-OUT clinical trial found it provided a relative risk reduction of 50%.

Developed in collaboration with Ridgeback Biotherapeutics, molnupiravir is an oral prodrug of the antiviral ribonucleoside analog N-hydroxycytidine (NHC). The drug’s mode of action is to contribute to errors in the viral genome during replication.

FDA has signaled it has questions about the drug’s safet…

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Pfizer bolsters COVID-19 antiviral manufacturing capacity

Although Pfizer (NYSE:PFE) has yet to receive emergency use authorization for its Paxlovid COVID-19 therapy, it plans to manufacture 80 million courses of the drug by the end of 2022. Pfizer had initially planned on making 50 million courses of Paxlovid (PF-07321332/ritonavir) in the same time frame.

An interim analysis of the Phase 2/3 EPIC-HR study found the drug to be 89% effective at reducing hospitalization or death. Pfizer announced the launch of a Phase 1 study of PF-07321332 in March.

Pfizer has inked a $5.29 billion Paxlovid deal with the U.S. government.

One course of oral Paxlovid therapy would consist of two daily 150-mg doses for five days.

Meanwhile, molnupiravir, the antiviral from Merck (NYSE:MRK) and Ridgeback Biotherapeutics, has lost some of its luster. New data suggests the drug led to an absolute risk reduction against hospitalization or death of 3% compared to placebo. Furthermore, the drug led to a relative risk reduction of…

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Pfizer to make COVID-19 pill available in low- and middle-income nations

In late October, Merck (NYSE:MRK) and its partner Ridgeback Biotherapeutics agreed to make the COVID-19 antiviral molnupiravir available in the developing world.

Now, Pfizer (NYSE:PFE) is taking a similar approach for its investigational antiviral cocktail Paxlovid, which contains PF-07321332 and ritonavir.

Pfizer, like Merck, struck an agreement with the Medicines Patent Pool (MPP) related to Paxlovid.

MPP’s mission is to expand low- and middle-income countries’ access to vital medicines. The United Nations supports the organization.

Pfizer announced earlier this month that Paxlovid was 89% effective in reducing the risk of hospitalization or death in an interim analysis of the Phase 2/3 EPIC-HR trial.

The collaboration with MPP will enable generic drug makers internationally with sub-licenses to produce Paxlovid for use in 95 countries, which comprise more than half of the world’s population.

“This license is so important because, …

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Japanese government agrees to buy 1.6 million molnupiravir courses

Image courtesy of Merck & Co.

Merck & Co. (NYSE:MRK) and its partner Ridgeback Biotherapeutics will sell approximately 1.6 million courses of the COVID-19 antiviral molnupiravir (MK-4482, EIDD-2801).

In related news, Thailand announced that it intends to purchase 50,000 courses of the drug while Taiwan plans on obtaining 10,000 courses. 

The U.S. plans on purchasing roughly 3.1 million courses of molnupiravir. 

The UK authorized the drug last week. 

Assuming molnupiravir receives authorization or approval in Japan, Merck stands to gain approximately $1.2 billion to cover the 1.6 million courses. That equates to roughly $750 per course — slightly higher than the going rate in the U.S. 

The company has also taken steps to ensure the drug is affordable in developing countries. For example, it is offering tiered pricing based on nations’ economic means and has also granted vol…

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U.S. to buy 1.4 million additional courses of molnupiravir

Merck (NYSE:MRK) and Ridgeback Biotherapeutics appear to be gaining growing support for their oral COVID-19 therapy molnupiravir.

One week after Great Britain granted conditional marketing authorization for the drug, the companies announced that the U.S. government intends to purchase 1.4 million additional medicine courses for approximately $1 billion.

The U.S. has committed to buy approximately 3.1 million molnupiravir courses for $2.2 billion, which equates to about $710 per course.

For the sake of comparison, the U.S. pays about $40 per dose of COVID-19 vaccines.

Molnupiravir photo courtesy of Merck.

The U.S. has the option of buying an additional 2 million courses of molnupiravir.

Merck and Ridgeback are awaiting news from FDA regarding their submission for emergency use authorization of molnupiravir. The application would cover adults with mild-to-moderate COVID-19 who have …

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UK approves Merck’s oral COVID-19 drug molnupiravir

The United Kingdom has become the first country to authorize molnupiravir, the oral antiviral drug from Merck (NYSE:MRK) and Ridgeback Biotherapeutics.

The Medicines and Healthcare products Regulatory Agency (MHRA) allowed conditional marketing authorization for the drug in Great Britain only. Furthermore, it has granted emergency use authorization of the drug for Northern Ireland.

MHRA recommends that the drug be used in people with mild-to-moderate COVID-19 who have at least one risk factor predisposing them to severe illness. MHRA further recommended that the drug be used as soon as possible after a positive COVID-19 test and “within five days of symptoms onset.”

Merck will market the drug as Lagevrio.

MHRA also noted that it does recommend the drug as an alternative to vaccination.

Merck has also vowed to make the drug available internationally, assuming it passes the requisite regulatory hurdles. Developing nations could pay approximat…

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Merck projects at least $5B in 2022 sales for molnupiravir 

Merck’s (NYSE:MRK) investigational oral COVID-19 drug could net between $5 billion and $7 billion in revenue through the end of 2022 if FDA authorizes its use in December, the company projected.

Sales of the drug could be higher, assuming it finds widespread use in wealthy countries.

Merck expects sales between $500 million and $1 billion for 2021.

Merck’s stock climbed more than 5% per share to $85.70 in mid-day trading.

Several other companies are also developing COVID-19 antivirals, including Pfizer and Novartis. Roche and Atea recently announced disappointing Phase 2 results involving their investigational antiviral AT-527.

Merck also announced that the molnupiravir, which it developed with Ridgeback Biotherapeutics, would be available in developing countries. To that end, Merck agreed to a royalty-free license for molnupiravir with the Medicines Patent Pool. As a result of the arrangement, generic drug manufacturers could sell a five-d…

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EMA begins rolling review of Merck’s and Ridgeback’s COVID-19 pill molnupiravir

Merck (NYSE: MRK) and its partner Ridgeback Biotherapeutics has announced that the European Medicines Agency (EMA) has begun a rolling review for molnupiravir, the experimental antiviral that could be the first oral treatment for COVID-19 to hit the market.

Merck has also submitted emergency use authorization (EUA) paperwork related to the drug to FDA.

The company is also pursuing marketing authorization in other countries across the globe.

“This application to the EMA is another step in our efforts to bring molnupiravir forward to patients globally,” said Dr. Dean Y. Li, executive vice president and president, Merck Research Laboratories, in a statement.

Interim data from the Phase 3 MOVe-OUT clinical trial found that the drug effectively reduced symptom progression in non-hospitalized patients with mild-to-moderate COVID-19. The patients in that study were deemed to have an elevated risk of developing severe COVID-19 or hospitalization.


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