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Merck, known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the refusal of the marketing authorization for Lagevrio (molnupiravir) for the treatment of certain adults who have been diagnosed with Covid-19 in the European Union (EU). Merck and Ridgeback will appeal the decision and request a re-examination of the CHMP’s opinion.
“We believe the CHMP’s recommendation does not reflect the compelling data generated from the phase 3 MOVe-OUT trial and from real-world studies demonstrating the positive impact that Lagevrio can provide for patients by reducing the risk of hospitalization and death among adults at increased risk for severe disease,” said Dr. Dean Y. Li, president, Merck Research Laboratories. “More than 4 million patients worldwide have been treated with Lagevrio. We remain Confident that Lagevrio has an important role to play in the Covid-19 treatment landscape and will appeal this opinion.”
“Lagevrio is prescribed globally as an important medicine for appropriate adult patients at risk for severe disease, and there is a critical need for multiple approaches to treat Covid-19,” said Wendy Holman, chief executive officer, Ridgeback Biotherapeutics.
The EMA scientific opinion under Article 5(3) of Regulation (EC) 726/2004, which has supported the decision by 16 EU national authorities to make Lagevrio available, remains in effect.
Lagevrio is approved or authorized for use in more than 25 countries, including Australia, Japan, the United States, the United Kingdom, and China for the treatment of certain adults who have been diagnosed with Covid-19. Lagevrio has been used in more than 4 million patients worldwide, and recent real-world studies – conducted across different geographies during the Omicron variant surge and as availability of effective vaccines has increased – support the clinical profile of Lagevrio as a treatment option for certain adults with mild to moderate Covid-19 who are at high risk for severe disease.
Global access has been a priority for Merck and Ridgeback since the inception of their collaboration. The companies are committed to providing timely access to Lagevrio globally through our comprehensive supply and access approach, which included investing at risk to produce millions of courses of therapy; tiered pricing based on the ability of governments to finance health care; entering into supply agreements with governments; and granting voluntary licenses to generic manufacturers and to the Medicines Patent Pool to make generic molnupiravir available in more than 100 low- and middle-income countries following local regulatory authorizations or approvals. To supplement the supply from licensed generic manufacturers and bridge to the availability of WHO prequalified generic supply, Merck entered into agreements with UNICEF and USAID to allocate up to a total of 5 million courses of Lagevrio to low- and middle-income countries.
The US Food and Drug Administration (FDA) has issued an EUA for the emergency use of the unapproved product Lagevrio, a nucleoside analogue that inhibits SARS-CoV-2 replication by viral mutagenesis, for the treatment of adults with a current diagnosis of mild-to-moderate coronavirus disease 2019 (Covid-19) who are at high risk for progression to severe Covid-19, including hospitalization or death, and for whom alternative Covid-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate. Lagevrio is not FDA-approved for any use, including the treatment of Covid-19.
The emergency use of Lagevrio is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the Covid-19 pandemic under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1) unless the declaration is terminated or authorization revoked sooner.
Lagevrio is not authorized for use in patients less than 18 years of age or for initiation of treatment in patients hospitalized due to Covid-19. Benefit of treatment with Lagevrio has not been observed in subjects when treatment was initiated after hospitalization due to Covid-19. Lagevrio is not authorized for use for longer than five consecutive days. Lagevrio is not authorized for pre-exposure or post-exposure prophylaxis for prevention of Covid-19. Lagevrio may only be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs in the therapeutic class to which Lagevrio belongs (i.e., anti-infectives).
Lagevrio (molnupiravir) (MK-4482) is an investigational, orally administered nucleoside analog that inhibits the replication of SARS-CoV-2, the causative agent of Covid-19.
Merck and Ridgeback’s “orange Covid-19 pill” is a Swedish Orange opaque capsule with the Merck corporate logo and “82” printed in white ink, available in certain markets as Lagevrio.
Molnupiravir was invented at Emory University. Drug Innovation Ventures at Emory (DRIVE), LLC, which was formed by Emory to develop early-stage drug candidates for viral diseases of global concern, advanced molnupiravir through IND submission. Emory/DRIVE received some research funding from the US Department of Defense and the US National Institutes of Health.
Lagevrio is being developed by Merck 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 Lagevrio have been provided by Merck and Ridgeback.
Lagevrio was evaluated in MOVe-OUT, a global phase 3, randomized, placebo-controlled, double-blind, multi-site study of non-hospitalized adult patients with symptomatic, laboratory-confirmed mild to moderate Covid-19 and at least one risk factor associated with poor disease outcomes. The Phase 3 portion of the MOVe-OUT trial was conducted globally in more than 170 sites in locations including Argentina, Brazil, Canada, Chile, Colombia, Egypt, France, Germany, Guatemala, Israel, Italy, Mexico, Philippines, Poland, Russia, South Africa, Spain, Sweden, Taiwan, Ukraine, the United Kingdom and the United States.
Lagevrio is being studied in other diseases beyond coronaviruses. Early work on additional programs has begun, and a study evaluating LAGEVRIO for RSV (NCT05559905) is recruiting participants.
Headquartered in Miami, Florida, Ridgeback Biotherapeutics LP is a biotechnology company focused on emerging infectious diseases. Ridgeback markets Ebanga for the treatment of Ebola and has a late-stage development pipeline which includes molnupiravir for the treatment of Covid-19.
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