molnupiravir Archives - Medical Design Sourcing

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.<…

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…

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.

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…

Why Public Citizen is skeptical about the COVID-19 antiviral molnupiravir

Dr. Michael Carome, director of Public Citizen’s health research group, is concerned about Merck’s SARS-CoV-2 antiviral molnupiravir.

If it wins emergency use authorization (EUA), molnupiravir would be the first oral treatment for COVID-19. But Carome brought up several potential problems with molnupiravir during today’s public comment period of the FDA’s Antimicrobial Drugs Advisory Committee meeting.

First, Carome argued that the drug appeared to have modest efficacy, offering a relative risk reduction against hospitalization or death of 30% through day 29 of the MK-4482-002 Phase 2/3 study.

Get the full story from our sister site, Drug Discovery & Development.

Why Public Citizen is skeptical about the COVID-19 antiviral molnupiravir

Dr. Michael Carome, director of Public Citizen’s health research group, is concerned about Merck’s SARS-CoV-2 antiviral molnupiravir.

If it wins emergency use authorization (EUA), molnupiravir would be the first oral treatment for COVID-19. But Carome brought up several potential problems with molnupiravir during today’s public comment period of the FDA’s Antimicrobial Drugs Advisory Committee meeting.

First, Carome argued that the drug appeared to have modest efficacy, offering a relative risk reduction against hospitalization or death of 30% through day 29 of the MK-4482-002 Phase 2/3 study.

Additionally, subgroup analyses of the MK-4482-002 study showed that the drug’s potential benefits appeared to be “substantially lower” in patients infected with the SARS CoV-2 Delta variant when the drug was provided at the proposed dosage of 800 mg every 12 hours for five days.

“Subgroup analyses also found n…

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…

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 …

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…

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.

O…

Everest Organics begins manufacturing API for molnupiravir

Molnupiravir photo courtesy of Merck.

Bengaluru, India–based Everest Organics (BOM:524790) saw its share price jump 15% today to ₹347.10 after announcing it has begun manufacturing the active pharmaceutical ingredient (API) for a molnupiravir generic.

Molnupiravir is an experimental oral drug that appears to substantially reduce the rate of COVID-19-related hospitalization for patients with mild-to-moderate infections.

Reuters has reported that molnupiravir developer Merck (NYSE:MRK) has agreements with multiple Indian companies related to the manufacture of the drug.

Merck partnered with Ridgeback Biotherapeutics in developing molnupiravir, which scientists with ties to Emory University initially discovered.

“After the successful development and commercialization of various COVID-19 drugs, such as Oseltamivir, Remdesivir, [and] Posaconazole, Everest Organics Limited is on its path of …

A course of Merck’s COVID-19 pill could cost more than $700

Merck’s (NYSE:MRK) oral drug molnupiravir (MK-4482) could be a COVID-19 game-changer, assuming it wins emergency use authorization.

The medicine could also be lucrative for Merck, assuming it finds widespread use.

Costing $712 for a treatment course, according to a contract obtained by Knowledge Ecology International, molnupiravir’s retail cost would be almost 40 times more than its production cost. It takes about $17.74 to produce a five-day course of the drug, according to an estimate from a pricing analysis from the Harvard School of Public Health and King’s College Hospital in London.

Knowledge Ecology International obtained the contract via a Freedom of Information Act lawsuit targeting the HHS and the Army regarding U.S. government COVID-19 contracts.

Merck did not immediately respond to a request for comment on its pricing plans related to the drug.

In initial contracts with the U.S., the Pfizer-BioNTech vaccine has a price tag of $1…