• CDC
  • Heart Failure
  • Cardiovascular Clinical Consult
  • Adult Immunization
  • Hepatic Disease
  • Rare Disorders
  • Pediatric Immunization
  • Implementing The Topcon Ocular Telehealth Platform
  • Weight Management
  • Screening
  • Monkeypox
  • Guidelines
  • Men's Health
  • Psychiatry
  • Allergy
  • Nutrition
  • Women's Health
  • Cardiology
  • Substance Use
  • Pediatrics
  • Kidney Disease
  • Genetics
  • Complimentary & Alternative Medicine
  • Dermatology
  • Endocrinology
  • Oral Medicine
  • Otorhinolaryngologic Diseases
  • Pain
  • Gastrointestinal Disorders
  • Geriatrics
  • Infection
  • Musculoskeletal Disorders
  • Obesity
  • Rheumatology
  • Technology
  • Cancer
  • Nephrology
  • Anemia
  • Neurology
  • Pulmonology

FDA Fast Tracks Ensitrelvir, Investigational Antiviral Targeting SARS-CoV-2 Replication

Article

The US Food and Drug Administration (FDA) recently granted Fast Track designation to ensitrelvir fumaric acid for the treatment of COVID-19, according to a statement from manufacturer Shionogi.

Ensitrelvir, known as Xoxcova®125 mg in Japan, is an investigational oral 3CL protease inhibitor designed to suppress replication of the SARS-CoV-2 virus. While the drug has been given emergency regulatory approval in Japan, it is still an investigational agent outside the country.

The FDA’s decision to fast-track review of the antiviral was based on phase 3 data from the SCORPIO-SR study. SCORPIO-SR evaluated ensitrelvir safety and efficacy in persons with mild-to-moderate COVID-19 who were enrolled regardless of risk factors for COVID-19 progression. The cohort was more than 90% vaccinated against COVID-19. A total of 1203 patients from Japan, South Korea, and Vietnam received either ensitrelvir 125mg, with an initial loading dose of 375mg (n=603), or placebo (n=600) orally once daily for 5 days, within 5 days of symptom onset.

SCORPIO-SR investigators reported that treatment with ensitrelvir met the study’s primary endpoint demonstrating a statistically significant reduction in the time to resolution of 5 symptoms of COVID-19, compared with placebo (167.9 hours vs 192.2 hours; median time difference, 24.3 hours; P=.0407). Further, they observed a significant reduction in the time to achieve a negative infectious viral titer (secondary endpoint) in the ensitrelvir arm compared with the placebo arm (median time, 36.2 hours vs 65.3 hours; P<.001).

The phase 3 study was conducted during the Omicron-dominant phase of the epidemic.

There were no serious treatment-related adverse events during the study, according to the company statement, with the most commonly reported being a temporary decrease high-density lipoprotein and increased blood triglycerides, findings consistent with previous studies of ensitrelvir.

“There is a need for additional COVID-19 treatment options as SARS-CoV-2 continues to affect people in the US. Receiving Fast Track designation from the FDA recognizes the potential of ensitrelvir as a once-daily, oral antiviral for SARS-CoV-2,” said Nathan McCutcheon, CEO, Shionogi Inc, the US subsidiary of Shionogi. “We look forward to our continued discussions with the FDA to bring ensitrelvir to patients as soon as possible.”


Recent Videos
"Vaccination is More of a Marathon than a Sprint"
Vaccines are for Kids, Booster Fatigue, and Other Obstacles to Adult Immunization
Tezepelumab Significantly Reduced Exacerbations in Patients with Severe Asthma, Respiratory Comorbidities
Document COVID Sequelae and Primary Care: An Interview with Samoon Ahmad, MD
© 2024 MJH Life Sciences

All rights reserved.