Fda

• 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. • This development is significant as it provides a preventative option for individuals exposed to the virus in high-risk environments, including nursing homes, acute care facilities, and during travel.

• 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. • This approval expands the available pharmaceutical toolkit for infectious disease management, offering a preventative oral alternative to existing treatments.

• 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. • This marks a significant shift in prevention strategy, though the medication is currently not approved for treating active COVID-19 infections within the U.S.

• During the week of June 19, 2023, the FDA issued several key approvals, including a $3.2 million gene therapy and the first anti-inflammatory drug designed for cardiovascular disease. • Other approved treatments include a subcutaneous version of Vyvgart for myasthenia gravis and the expansion of Jardiance and Synjardy for pediatric patients with type 2 diabetes. • Conversely, the agency rejected three therapies targeting nonalcoholic steatohepatitis (NASH), retinal cancer, and rare fungal infections.

• Following the resignation of Commissioner Marty Makary, the FDA is seeking a new leader to oversee the agency's commitment to accelerating treatment access for rare disease patients. • The urgency is highlighted by UX111 gene therapy, which clinical trials show can reduce toxin buildup for over eight years and slow cognitive decline if administered early. • This transition is critical because children unable to access UX111 through clinical trials continue to suffer irreversible losses while awaiting formal FDA approval.

• The FDA approved Icotyde (icotrokinra), developed by Johnson & Johnson Innovative Medicine, on March 17, 2026. • The drug is an interleukin-23 (IL-23) receptor antagonist specifically indicated for patients with moderate-to-severe plaque psoriasis. • This approval provides a new therapeutic option for managing a chronic inflammatory skin condition by targeting specific immune responses.

• An FDA advisory panel will convene this Thursday to determine which Covid-19 strain vaccine manufacturers should target for the 2026-2027 season. • The meeting occurs as the United States continues to navigate a shifting vaccine infrastructure and evolving public health needs. • Separately, an experimental Ebola vaccine developed by an Oxford team is approaching the production phase for upcoming clinical trials.