United Kingdom becomes first country to approve Emory-discovered drug for COVID-19
Woodruff Health Sciences Center | Nov. 4, 2021
An Emory-invented antiviral treatment for COVID-19 was authorized today by British regulators, making molnupiravir the first antiviral pill approved for use against SARS-CoV-2. An emergency use application is also under consideration by the U.S. Food and Drug Administration.
An Emory University-invented antiviral treatment for COVID-19 was authorized today by British regulators. The approval of molnupiravir (also known as Lagevrio), by the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA), provides patients with the first antiviral pill approved for use against SARS-CoV-2.
In early October, Merck and Ridgeback Biotherapeutics, which developed the drug after licensing it from Drug Innovation Ventures at Emory (DRIVE), reported that a Phase 3 study showed that molnupiravir significantly reduced the risk of hospitalization or death in patients with mild to moderate COVID-19.
In a statement, the MHRA noted that based on the clinical trials data, molnupiravir is most effective when taken during the early stages of infection and recommended its use “as soon as possible following a positive COVID-19 test and within five days of symptoms onset.”
“Emory scientists worked for years to discover and develop molnupiravir, and today’s approval in the U.K. is a major step forward in the fight against COVID-19,” says Emory President Gregory L. Fenves. “I appreciate our partners Merck and Ridgeback for bringing this new drug through the U.K. regulatory approval process. This is Emory at its best, addressing the challenges of our time and transforming research into real world solutions.”
When the COVID-19 pandemic began, researchers at DRIVE quickly repurposed a broad-spectrum antiviral drug they had been developing for infectious diseases.
"I have been a strong advocate of the DRIVE team since my arrival to Emory almost six years ago and this success is testament to their tremendous perseverance and effort," says Dr. Jonathan S. Lewin, executive vice president for health affairs and executive director of Woodruff Health Sciences Center at Emory University. "It's exciting to see DRIVE's work recognized, and that people around the world will soon have access to a therapeutic that will improve lives and provide hope."
U.K regulators have authorized molnupiravir for use in patients with mild to moderate COVID-19 and at least one risk factor for developing severe illness. Risk factors cited by MHRA include obesity, age (60+), diabetes, or heart disease.
The U.S. Food and Drug Administration (FDA) is currently considering Merck and Ridgeback’s application for emergency use authorization. The agency has convened an advisory panel on Nov. 30 to discuss the safety and efficacy of the drug.
Emory University's mission is to create, preserve, teach, and apply knowledge in the service of humanity. Emory’s work is well positioned to go from bench to bedside because of its outstanding researchers and facilities, which include state-of-the-art research laboratories, and a comprehensive health system that can host clinical trials for the next lifesaving drug or vaccine.
Emory formed DRIVE to advance the development of early-stage drug candidates to address viral diseases of global concern. DRIVE has a leadership team with deep industry experience and applies an entrepreneurial mindset and the focus of a biotechnology company to address the world’s need for therapies that address pandemics, an area that for-profit companies have historically neglected. By taking advantage of Emory’s renowned research enterprise, DRIVE increases the probability that promising drugs will be developed for the ultimate benefit of humanity.