FDA fast-tracks promising hepatitis B drug after ‘remarkable’ trial results

• The U.S. FDA has approved ensitrelvir (Xocova), an oral antiviral developed by Shionogi, for the post-exposure prevention of COVID-19. • The medication is authorized for use in individuals aged 12 years and older who have been exposed to the SARS-CoV-2 virus.

• The FDA has approved Shionogi’s Xocova (ensitrelvir) as the first oral therapy designed to prevent Covid-19 after a person has been exposed to the virus. • The approval follows the Scorpio-Pep trial involving 2,387 participants aged 12 and older who were asymptomatic but had been exposed to a symptomatic household member.

• Missouri State Rep. Dave Griffith is advocating for psychedelic-assisted therapy to treat veterans suffering from depression and post-traumatic stress disorder. • The initiative follows an April executive order signed by Donald Trump titled “Accelerating Medical Treatments for Serious Mental Illness,” which aims to speed up drug approvals and clinical trial participation.

• WHO Director General Tedros Adhanom Ghebreyesus visited health workers at the Evangelical Medical Centre in Bunia, Congo, on May 31, 2026. • The visit addresses an outbreak of the Bundibugyo virus, which is currently concentrated in Congo's eastern Ituri province.

• Merck (known as MSD outside the U.S. and Canada) announced the publication of new clinical trial work on May 7, 2026. • The announcement was distributed via Business Wire from Rahway, N.J., targeting both healthcare professionals and consumers.

• Shionogi has received FDA approval for its protease inhibitor, ensitrelvir, specifically for use in the prevention of COVID-19. • This regulatory win follows a previous failure by the company to demonstrate the drug's effectiveness as a primary treatment for U.S. patients.

• The FDA has approved ensitrelvir, an oral antiviral medication specifically designed to prevent COVID-19 after a person has been exposed to the virus. • Approval follows the phase III SCORPIO-PEP trial, which demonstrated that the drug reduced the risk of developing COVID-19 by more than half for individuals who were household contacts of an infected person.

• The FDA has approved XOCOVA (ensitrelvir), developed by Shionogi Inc., as a new treatment option for COVID-19. • XOCOVA is distinguished as the first and only oral medication specifically approved to help prevent the onset of COVID-19 following exposure to the virus.

• The FDA has approved the oral medication ensitrelvir for use as post-exposure prophylaxis (PEP) to prevent the onset of COVID-19 symptoms. • Approval follows phase 3 clinical trial data conducted between February 10 and July 10, 2022, across 92 sites in Japan, Vietnam, and South Korea, demonstrating efficacy against Omicron variants.

• The FDA recently approved the oral antiviral drug ensitrelvir (Xocova) for use as post-exposure prophylaxis (PEP). • The medication is designed to be taken within 72 hours after a person has been exposed to someone with COVID-19 to prevent infection.

• The April 24, 2026, Health Equity & Access roundup highlighted critical systemic inequities, specifically focusing on Black maternal mortality, youth impact of the 988 crisis line, and gaps in food assistance. • Medical panelists advocated for universal biomarker testing in lung cancer and the expanded use of minimal residual disease testing to improve diagnostic workflows and patient outcomes.