Merck Seeks Emergency Approval For Investigational Oral Drug To Treat COVID: “This is going to change the dialogue around how to manage COVID-19”
A major drug manufacturer has announced a new oral antiviral drug they claim could cut the chances of dying or being hospitalized in half for those most at risk of contracting severe COVID-19. According to Reuters, experts are hailing the investigational drug as a potential breakthrough in treating the virus.
Merck Chief Executive Robert Davis claims the new drug called molnupiravir “is going to change the dialogue around how to manage COVID-19.”
Reuters– If it gets authorization, molnupiravir, which is designed to introduce errors into the genetic code of the virus, would be the first oral antiviral medication for COVID-19.
Merck (MRK.N) and its partner Ridgeback Biotherapeutics plan to seek U.S. emergency use authorization for the pill as soon as possible and to make regulatory applications worldwide.
From Merck: Merck and Ridgeback’s Investigational Oral Antiviral Molnupiravir Reduced the Risk of Hospitalization or Death by Approximately 50 Percent Compared to Placebo for Patients with Mild or Moderate COVID-19 in Positive Interim Analysis of Phase 3 Study
At the Interim Analysis, 7.3 Percent of Patients Who Received Molnupiravir Were Hospitalized Through Day 29, Compared With 14.1 Percent of Placebo-Treated Patients Who were Hospitalized or Died
Merck Plans to Seek Emergency Use Authorization in the U.S. as Soon as Possible and to Submit Applications to Regulatory Agencies Worldwide
If Authorized, Molnupiravir Could be the First Oral Antiviral Medicine for COVID-19
In anticipation of the results from MOVe-OUT, Merck has been producing molnupiravir at risk. Merck expects to produce 10 million courses of treatment by the end of 2021, with more doses expected to be produced in 2022.
Earlier this year, Merck entered into a procurement agreement with the U.S. Government under which Merck will supply approximately 1.7 million courses of molnupiravir to the U.S. government, upon EUA or approval from the U.S. FDA. Additionally, Merck has entered into supply and purchase agreements for molnupiravir with other governments worldwide, pending regulatory authorization, and is currently in discussions with other governments.
Merck is committed to providing timely access to molnupiravir globally, if it is authorized or approved, and plans to implement a tiered pricing approach based on World Bank country income criteria to reflect countries’ relative ability to finance their health response to the pandemic.
As part of its commitment to widespread global access, Merck previously announced that the company has entered into non-exclusive voluntary licensing agreements for molnupiravir with established generic manufacturers to accelerate availability of molnupiravir in more than 100 low- and middle-income countries (LMICs) following approvals or emergency authorization by local regulatory agencies.
The announcement of the new drug by the major US drug company is bad news for the manufacturers of Ivermectin and Hydroxychloroquine, two inexpensive drugs that have been touted by scores of physicians as “cures” for COVID-19 after successfully treating their patients with the drugs. Facebook “fact-checkers” (also known as the ultimate authorities on modern medicine and treatments for viruses that originate from a lab in Communist China) have decided that Ivermectin and Hydroxychloroquine are not viable treatments for COVID, and anyone who suggests they are, should be punished. The censorship on the topic of alternate cures or treatments for COVID, including natural and homeopathic remedies that don’t come from a major drug manufacturer or lack the stamp of approval from the US government, has been nothing short of breathtaking.
If the US government has not yet approved the new Merck anti-viral drug, why has our government already committed to purchasing 1.7 million doses? Why are patients being denied potentially life-saving drugs like Ivermectin and Hydroxychloroquine, used for decades to safely treat other ailments in the US and worldwide?
