FDA Grants Fast Track Designation for Shionogi’s Investigational COVID-19 Oral Antiviral
Japanese multinational pharmaceutical company Shionogi & Co., Ltd,. announced at the beginning of April that the U.S. FDA has granted Fast Track designation for their investigational COVID-19 oral antiviral ensitrelvir.
The purpose of FDA Fast Track designation is to simplify the development process and accelerate the evaluation of prospective new treatments that address critical illnesses and meet a previously unmet medical requirement.
Ensitrelvir (ensitrelvir fumaric acid), also known as Xocova® 125 mg tablet in Japan, recently received emergency regulatory approval from the Ministry of Health, Labour and Welfare (MHLW) in Japan for the treatment of SARS-CoV-2 infection. It remains an investigational drug outside Japan.
COVID-19 is a serious and potentially lethal disease. As of mid-January 2023, there have been over 660 million reported cases worldwide, with the United States accounting for more than 101 million of those cases, as per the data provided by the CSSE at Johns Hopkins University.
Nathan McCutcheon, CEO, Shionogi Inc., the U.S. subsidiary of Shionogi said:
“There is a need for additional COVID-19 treatment options as SARS-CoV-2 continues to affect people in the U.S. Receiving Fast Track designation from the FDA recognizes the potential of ensitrelvir as a once-daily, oral antiviral for SARS-CoV-2.” “We look forward to our continued discussions with the FDA to bring ensitrelvir to patients as soon as possible.”
Ensitrelvir is an oral antiviral agent administered once daily for five days that suppresses the replication of SARS-CoV-2 by selectively inhibiting the viral 3CL protease. Shionogi recently presented results from the Phase 3 part of the pivotal SCORPIO-SR trial (Phase 2/3 study) conducted in Japan, South Korea, and Vietnam at the Conference on Retroviruses and Opportunistic Infections (CROI). Several additional Phase 3 clinical studies evaluating the safety and efficacy of ensitrelvir across a wide range of COVID-19 patient populations are planned and ongoing.
Shionogi is committed to “Protect people worldwide from the threat of infectious diseases” with research and development of therapeutics, while also working towards total care through awareness building, epidemiologic monitoring, prevention, diagnosis, and addressing exacerbations, as well as treating infections directly. As SARS-CoV-2 continues to have a major impact on people’s lives and to represent a global threat, Shionogi plans to contribute to re-establishing the safety and security of society by developing new products and services to address this pandemic. Shionogi is committed to equitable access worldwide, including working with the Medicines Patent Pool to provide access to low- and middle-income countries (LMICs), and strengthening its manufacturing and global supply chain.
Ensitrelvir (known in Japan as Xocova®), an oral antiviral drug for COVID-19, is currently approved under the emergency regulatory approval system in Japan. Ensitrelvir has not yet been approved outside of Japan, where it is still an investigational drug. In addition, the brand name Xocova® has not been approved for use outside of Japan and pertains only to the approved drug in Japan.
Ensitrelvir is a 3CL protease inhibitor created through joint research between Hokkaido University and Shionogi. SARS-CoV-2 has an enzyme called 3CL protease, which is essential for the replication of the virus. Ensitrelvir suppresses the replication of SARS-CoV-2 by selectively inhibiting 3CL protease.
Ensitrelvir is the first antiviral agent to show both clinical symptomatic efficacy for five typical Omicron-related symptoms (primary endpoint) and antiviral efficacy (key secondary endpoint) in a predominantly vaccinated population of patients with mild to moderate SARS-CoV-2 infection, regardless of risk factors in the Phase 3 part of the Phase 2/3 study conducted during the Omicron-dominant phase of the epidemic. With regard to safety, most adverse events were mild in severity and no deaths were seen in the study. Among the most common treatment-related adverse events were temporary decreases in high-density lipoprotein and increased blood triglycerides, as observed in previous studies. Currently, the Phase 2b/3 part of the Phase 2/3 study targeting SARS-CoV-2 infected persons who were asymptomatic or only had mild symptoms is being conducted in Asia, mainly in Japan.
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