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Posted by: thepinetree on 10/01/2021 10:17 AM
Updated by: thepinetree on 10/01/2021 10:17 AM
Expires: 01/01/2026 12:00 AM
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If Authorized Molnupiravir Could be the First Oral Antiviral Medicine for COVID-19 as Merck Plans to Seek Emergency Use Authorization in the U.S. & Worldwide!
Kenilworth, NJ...Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics today announced that molnupiravir (MK-4482, EIDD-2801), an investigational oral antiviral medicine, significantly reduced the risk of hospitalization or death at a planned interim analysis of the Phase 3 MOVe-OUT trial in at risk, non-hospitalized adult patients with mild-to-moderate COVID-19. At the interim analysis, molnupiravir reduced the risk of hospitalization or death by approximately 50%; 7.3% of patients who received molnupiravir were either hospitalized or died through Day 29 following randomization (28/385), compared with 14.1% of placebo-treated patients (53/377); p=0.0012. Through Day 29, no deaths were reported in patients who received molnupiravir, as compared to 8 deaths in patients who received placebo. At the recommendation of an independent Data Monitoring Committee and in consultation with the U.S. Food and Drug Administration (FDA), recruitment into the study is being stopped early due to these positive results. Merck plans to submit an application for Emergency Use Authorization (EUA) to the U.S. FDA as soon as possible based on these findings and plans to submit marketing applications to other regulatory bodies worldwide.
“More tools and treatments are urgently needed to fight the COVID-19 pandemic, which has become a leading cause of death and continues to profoundly affect patients, families, and societies and strain health care systems all around the world. With these compelling results, we are optimistic that molnupiravir can become an important medicine as part of the global effort to fight the pandemic and will add to Merck’s unique legacy of bringing forward breakthroughs in infectious diseases when they are needed most. Consistent with Merck’s unwavering commitment to save and improve lives, we will continue to work with regulatory agencies on our applications and do everything we can to bring molnupiravir to patients as quickly as possible,” said Robert M. Davis, chief executive officer and president, Merck. “On behalf of all of us at Merck, I thank our network of clinical investigators and patients for their essential contributions to the development of molnupiravir.”
“With the virus continuing to circulate widely, and because therapeutic options currently available are infused and/or require access to a healthcare facility, antiviral treatments that can be taken at home to keep people with COVID-19 out of the hospital are critically needed,” said Wendy Holman, chief executive officer of Ridgeback Biotherapeutics. “We are very encouraged by the results from the interim analysis and hope molnupiravir, if authorized for use, can make a profound impact in controlling the pandemic. Our partnership with Merck is critical to ensuring rapid global access if this medicine is approved, and we appreciate the collaborative effort to reach this important stage of development.”
About the Results of the Planned Interim Analysis
The planned interim analysis evaluated data from 775 patients who were initially enrolled in the Phase 3 MOVe-OUT trial on or prior to Aug. 5, 2021. At the time of the decision to stop recruitment based on the compelling interim efficacy results, the trial was approaching full recruitment of the Phase 3 sample size of 1,550 patients, with more than 90% of the intended sample size already enrolled.
Eligibility criteria required that all patients had laboratory-confirmed mild-to-moderate COVID-19, with symptom onset within 5 days of study randomization. All patients were required to have at least one risk factor associated with poor disease outcome at study entry. Molnupiravir reduced the risk of hospitalization and/or death across all key subgroups; efficacy was not affected by timing of symptom onset or underlying risk factor. Additionally, based on the participants with available viral sequencing data (approximately 40% of participants), molnupiravir demonstrated consistent efficacy across viral variants Gamma, Delta, and Mu.
The incidence of any adverse event was comparable in the molnupiravir and placebo groups (35% and 40%, respectively). Similarly, the incidence of drug-related adverse events was also comparable (12% and 11%, respectively). Fewer subjects discontinued study therapy due to an adverse event in the molnupiravir group (1.3%) compared to the placebo group (3.4%).
About Merck’s Efforts to Enable Access to Molnupiravir, if it is Granted EUA or Approval
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.
More About the MOVe-OUT Study
The MOVe-OUT trial (MK-4482-002) (NCT04575597) was a global Phase 3, randomized, placebo-controlled, double-blind, multi-site study of non-hospitalized adult patients with laboratory-confirmed mild to moderate COVID-19, at least one risk factor associated with poor disease outcomes, and symptom onset within five days prior to randomization. The primary efficacy objective of MOVe-OUT is to evaluate the efficacy of molnupiravir compared to placebo as assessed by the percentage of participants who are hospitalized and/or die from the time of randomization through Day 29.
The Phase 3 portion of the MOVe-OUT trial was conducted globally, including in more than 170 planned sites in countries including Argentina, Brazil, Canada, Chile, Colombia, Egypt, France, Germany, Guatemala, Israel, Italy, Japan, Mexico, Philippines, Poland, Russia, South Africa, Spain, Sweden, Taiwan, Ukraine, the United Kingdom and the United States. For further information about the MOVe-OUT trial, please visit clinicaltrials.gov.
The most common risk factors for poor disease outcome included obesity, older age (>60 years), diabetes mellitus, and heart disease. To date, the Delta, Gamma, and Mu variants have accounted for nearly 80% of the evaluable cases in the trial. Recruitment in Latin America, Europe, and Africa accounted for 55%, 23% and 15% of the study population, respectively.
About Molnupiravir
Molnupiravir (MK-4482/EIDD-2801) is an investigational, orally administered form of a potent ribonucleoside analog that inhibits the replication of SARS-CoV-2, the causative agent of COVID-19. Molnupiravir has been shown to be active in several preclinical models of SARS-CoV-2, including for prophylaxis, treatment, and prevention of transmission. Additionally, pre-clinical and clinical data have shown molnupiravir to be active against the most common SARS-CoV-2 variants. Molnupiravir was invented at Drug Innovations at Emory (DRIVE), LLC, a not-for-profit biotechnology company wholly owned by Emory University, and is being developed by Merck & Co., Inc. in collaboration with Ridgeback Biotherapeutics. Ridgeback received an upfront payment from Merck and also is eligible to receive contingent payments dependent upon the achievement of certain developmental and regulatory approval milestones. Any profits from the collaboration will be split between the partners equally. Since licensed by Ridgeback, all funds used for the development of molnupiravir have been provided by Merck and by Wayne and Wendy Holman of Ridgeback.
Molnupiravir is also being evaluated for post-exposure prophylaxis in MOVe-AHEAD, a global, multicenter, randomized, double-blind, placebo-controlled Phase 3 study, which is evaluating the efficacy and safety of molnupiravir in preventing the spread of COVID-19 within households. For more information, please visit http://merckcovidresearch.com.
About Ridgeback Biotherapeutics
Headquartered in Miami, Florida, Ridgeback Biotherapeutics LP is a biotechnology company focused on emerging infectious diseases. Ridgeback markets EbangaTM for the treatment of Ebola and has a late-stage development pipeline which includes molnupiravir for the treatment of COVID-19. Development of molnupiravir is entirely funded by Ridgeback Biotherapeutics and Merck & Co., Inc. All equity capital in Ridgeback Biotherapeutics, LP originated from Wayne and Wendy Holman, who are committed to investing in and supporting medical technologies that will save lives. The team at Ridgeback is dedicated to working toward finding life-saving and life-changing solutions for patients and diseases that need champions.
About Merck
For over 130 years, Merck, known as MSD outside the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases in pursuit of our mission to save and improve lives. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to prevent and treat diseases that threaten people and animals – including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases – as we aspire to be the premier research-intensive biopharmaceutical company in the world. For more information, visit www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA.
This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.
Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.
The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s 2020 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).
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No Subject
Posted on: 2021-10-01 10:25:34
By: Anonymous
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Thanks but no thank you! Got my Johnson & Johnson and staying safe. We can only do our individual responsibilities and eliminate COVID.
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Re:
Posted on: 2021-10-01 10:48:35
By: Anonymous
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Not a replacement for a vaccine. More of 'plan b' if you get the breakthrough. This is a great win for our fight...
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Re: thanks
Posted on: 2021-10-01 11:20:46
By: Anonymous
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Thank you President Trump for making this possible.
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Re: thanks
Posted on: 2021-10-01 18:11:26
By: Anonymous
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^Fuk that assshole.
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No Subject
Posted on: 2021-10-01 10:39:45
By: Anonymous
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This is a different approach than the vaccine. This would be more like an antibiotic your doctor would order if you test positive. This virus and it's mutations will be around for decades or more so this pill would be very beneficial.
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Posted on: 2021-10-01 11:04:14
By: Anonymous
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Science 1, AntiVaxx 0.
A triumph for science. Way to go!!
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Posted on: 2021-10-01 11:19:11
By: Anonymous
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Thank you President Biden
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Re: MANY THANKS TO BIDEN
Posted on: 2021-10-01 12:39:58
By: Anonymous
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Yes thanks a lot Biden, for abandoning American Citizens in Afghanistan, for the deaths of 13 US Military Personnel and the wounding of 18 others, two still in critical condition, the deaths of hundreds of Afghanistans. Thanks Biden for an overrun southern border on the verge of collapse, and setting hundreds of thousands of COVID positive illegals all across our nation and not getting them vaccinated but forcing Americans to be vaccinated and even firing them from their jobs. Thanks Biden for the inflation, for your incompetence for higher energy cost, for natural gas prices to double and this winter adding another 30% to the price. Thanks Biden for gas and diesel prices skyrocketing and stopping oil production here at home BUT Begging OPEC for more oil to be produced for us. Thanks for just killing over 11,000 jobs by shutting down the Keystone pipeline those lost jobs were worth TWO BILLION DOLLARS IN WAGES which meant two billion dollars to be spent, not to mention the families that lost their homes. Thanks Biden for stabbing our oldest Allie, the French in the back, not. Thanks Biden for actually stabbing all of our Allies in the back with your stupidity when you had no idea what so ever when you made the biggest, most embarrassing blunder of me fern times on your botched pull out of Afghanistan. Not only did you not tell our Allies, you were to embarrassed to call them back after repeated calls to you, by them. Thanks Biden for showing the entire world how weak and frail you are. Our adversaries are not afraid of us, they actually laugh at us now from your constant disasters you have created, one crisis after another and you have NOT fixed one yet!!! Thanks Biden, President Trump gave you Three Vaccines and you bad mouthed the vaccines saying you wouldn't trust a vaccine from Trump if he said to take it. Thanks Biden, Everytime you open your mouth something incredibly stupid comes out of it. Thanks Biden for accusing our Border Patrol of whipping migrants without knowing the facts of what you are even talking about. Thanks Biden for threatening to fire all of our Border Patrol Agents who don't get vaccinated, but the legislative or judicial branches of government are required and of course illegal immigrants. Thanks Biden, because of you the peace that we had in the Middle East was shattered because you are delusional on any thing that has to do with Foreign Policy. Thanks Biden for throwing 100's of Millions of dollars to strengthening Afghanistan's border and allowing ours to go to HELL. All of your Generals that you didn't take their advise on Afghanistan also said our Southern Border is where our next 9/11 TERRORIST WILL BE COMING IN FROM BECAUSE OF YOUR INCOMPETENCE.
Yeah, thanks a Fuking lot Biden, for letting America suffer through your stupidity. I'm sure your son the Drug Addict, Alcoholic, the finger painting artist that will be making millions off your presidency to launder money, make illegal business deals with foreign politicians and our adversaries won't be investigated by the DOJ, the FBI we as citizens can only pray that you and your son get what's coming to you before our country suffers needlessly.
Thanks Biden for showing all of America that you and your family making money by corruption is more important to you then your Country, but what would we expect from a FIVE TIME DRAFT DODGING COWARD?
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Re: MANY THANKS TO BIDEN
Posted on: 2021-10-01 15:21:53
By: Anonymous
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Draft Dodging Coward.
Unlike Trump, who just found the right doctor(s) that found a medical condition that kept him from going to Vietnam.
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Re: MANY THANKS TO BIDEN
Posted on: 2021-10-01 16:35:50
By: Anonymous
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That's telling off these ass hole Demorats!
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Re: MANY THANKS TO BIDEN
Posted on: 2021-10-01 20:15:28
By: Anonymous
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TLDR
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Re:
Posted on: 2021-10-01 13:14:37
By: Anonymous
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For what Fuk that old Fuk...
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No Subject
Posted on: 2021-10-01 11:21:02
By: Anonymous
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$7,000 per treatment instead of a free vaccine?
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No Subject
Posted on: 2021-10-01 11:46:41
By: Anonymous
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This lessens the effects of the mutation viruses AFTER you have received the vaccine - that is IF you get a mutation like what some already vaccinated people are coming down with now.
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Posted on: 2021-10-01 13:15:53
By: Anonymous
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Is it called the morning after pill?
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Posted on: 2021-10-01 13:30:32
By: Anonymous
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Sniveler like a old Timex watch he'll give you a good licking and keep on ticking...
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Posted on: 2021-10-01 13:45:39
By: Anonymous
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Could Be...if you were intimate with a positive COVID individual the night before who also ripped off your mask!!
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Posted on: 2021-10-01 13:52:40
By: Anonymous
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Great job . President Biden
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Re:
Posted on: 2021-10-01 13:54:23
By: Anonymous
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I just need 11,780 votes . For the Republican Party to overthrow the constitution .
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