The U.S. Food and Drug Administration has cleared the first oral pill aimed at preventing COVID‑19 after someone has already been exposed, a five‑day prescription course for people 12 and older. Marketed as Xocova (ensitrelvir), the drug was tested in a large household study and cut the risk of developing symptomatic infection by roughly two‑thirds when started soon after contact with a COVID‑positive person.
Shionogi announced on June 1 that the FDA approved XOCOVA (ensitrelvir) for post‑exposure prophylaxis (PEP) in adults and adolescents 12 years and older, according to Shionogi. The company says the regimen is three tablets on day one followed by one tablet daily on days two through five, and the approval was also reported by AJMC.
SCORPIO‑PEP Trial Found a Large Benefit
The FDA cited results from the global Phase 3 SCORPIO‑PEP study, which enrolled more than 2,300 household contacts and, among participants who were uninfected at enrollment, found a 67% reduction in symptomatic COVID‑19 through day 10 for people given ensitrelvir versus placebo, as published in the New England Journal of Medicine. The trial required treatment to begin within 72 hours of the household case's symptom onset, and the primary analysis included roughly 2,041 participants whose central lab tests were negative at baseline.
What This Means for Atlanta
Because XOCOVA is a prescription medicine meant to be taken after a known exposure, local access in Atlanta will depend on how readily clinicians choose to prescribe it, as well as pharmacy supply and insurance coverage. Payers and pharmacy benefit managers are already watching the drug's rollout and potential demand, industry analysts told Fierce Healthcare.
Shionogi's prescribing information warns of important drug interactions and lists medications that should not be taken with XOCOVA. Common side effects in the SCORPIO‑PEP trial included headache, diarrhea and cough, and overall adverse‑event rates were similar between the drug and placebo groups, according to Shionogi. The company also notes that XOCOVA is approved in the U.S. for post‑exposure prophylaxis but is not authorized for the treatment of COVID‑19 here.
If you live in Atlanta and were exposed to someone with COVID‑19, contact your doctor or local pharmacist to ask whether XOCOVA might be appropriate and how to obtain it. For a straightforward local breakdown of the approval and what Atlantans should know, see the report by Atlanta News First.
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