In continuation of my update on ensitrelvir
Shionogi & Co., Ltd. (Head
Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, PhD; hereinafter
“Shionogi”) announced that the U.S. Food and Drug Administration (FDA) has
approved Xocova (ensitrelvir),
an oral antiviral, for post-exposure prophylaxis (PEP) of COVID‑19 in adults
and adolescents 12 years of age and older following contact with an individual
who has COVID-19.3 This approval introduces the first and only
oral option to help prevent COVID-19 after exposure in the current therapeutic
landscape, addressing a critical gap in prevention. Xocova is a five-day oral
regimen with three tablets taken on day one and one tablet taken on days two
through five.3 The approval occurred ahead of the Prescription
Drug User Fee Act (PDUFA) action date of June 16, 2026.
- Approval is based on SCORPIO-PEP, the only Phase
3 study of an oral antiviral to meet the primary endpoint of preventing
symptomatic COVID-19 following exposure to an infected individual*
- Xocova offers a new approach to help prevent
COVID-19 by blocking viral replication during the critical window between
exposure and COVID-19 symptom onset1,2
“The FDA approval of Xocova
provides an important new approach to preventing COVID-19, which continues to
impact lives. COVID-19 can become severe and even when mild or moderate, it can
worsen or exacerbate chronic conditions or trigger new ones, including long
COVID,” said Frederick Hayden, MD, Richardson Professor Emeritus of Clinical
Virology and Professor Emeritus of Medicine, University of Virginia School of
Medicine. “Ensitrelvir inhibits viral replication, helping protect people who
have been exposed to COVID-19 from developing illness. The PEP strategy has the
potential to benefit anyone who does not want to get COVID-19. It could be
useful not only in household settings but also in other exposure circumstances,
such as outbreaks in nursing homes, chronic or acute care facilities and
following travel-related exposures.”
The approval is based on positive
results from SCORPIO-PEP, the only Phase 3 study of an oral antiviral to meet
the primary endpoint of preventing symptomatic COVID-19 following exposure to
an infected individual.* Xocova significantly reduced the risk of symptomatic
COVID-19 by 67% in uninfected individuals following exposure to an infected
individual through Day 10 compared with placebo (ensitrelvir
n=1,030; placebo n=1,011). 3,4 Overall, Xocova was
generally well tolerated, with similar rates of adverse events across groups
(15.1% in the Xocova group (n=1,190) and 15.5% in the placebo group (n=1,187)).4 The
most common adverse events (regardless of causality) occurring in greater than
or equal to 1% of the Xocova group and at a greater frequency compared to
placebo were headache, diarrhea, and cough. 3 There were
no reports of altered taste (dysgeusia) attributed to Xocova in the trial.4,5 Results
from the SCORPIO-PEP trial were published in the New England Journal of
Medicine on May 14, 2026.
“The FDA approval of Xocova is an
exciting new chapter in the Shionogi antiviral story, which includes innovative
medicines that have changed the way we manage other viruses including HIV and
influenza,” said Nathan McCutcheon, President and CEO, Shionogi Inc. “Xocova is
the first and only oral option clinically proven to help prevent symptomatic
COVID-19 after exposure among study participants regardless of vaccination
status or baseline immunity from prior infection. With Xocova, people who are
exposed to COVID-19 can act early to help protect themselves.”
The impact of this matter on the
consolidated financial results for the fiscal year ending March 2027 has
already been reflected in the earnings forecast announced on May 12, 2026.
The Ongoing Impact of
COVID-19
COVID-19 remains highly
transmissible, driven by Omicron and its subvariants, and up to 47% of people
living with an infected individual may develop COVID-19.6 The
U.S. Centers for Disease and Control estimates that between October 1, 2025 and
May 23, 2026 there were 3.8-12.4 million new cases in the U.S., resulting in
800,000 – 2.3 million outpatient visits, 120,000 – 240,000 hospitalizations and
13,000 - 42,000 deaths.7
Beyond acute infection, COVID-19
can have lasting impacts. People diagnosed with COVID-19 had increased rates of
both new and worsening neurologic, cardiovascular, respiratory, and renal
conditions during the year following infection.8-17 COVID-19
also disproportionately affects older adults with greater risk for severe
illness and death in close-community settings, such as long-term care
facilities.18
About SCORPIO-PEP
The global, double-blind,
randomized, placebo-controlled Phase 3 study, SCORPIO-PEP, assessed the safety
and efficacy of Xocova as post-exposure prophylaxis for COVID-19. The study
included 2,387 study participants aged 12 years and older with a negative local
screening test for SARS-CoV-2 infection and no symptoms at the time of
enrollment, who were exposed to a person living in their household with
symptomatic COVID-19. The primary analysis included 2,041 household contact
participants with a central laboratory-confirmed negative SARS-CoV-2 test at
baseline.
The trial was conducted from June
2023–September 2024. More than 99% of household contacts tested positive for
antibodies against SARS-CoV-2 N (nucleocapsid) or S (spike) proteins,
indicating that nearly all had evidence of previous SARS-CoV-2 infection or
vaccination, or both.
Study participants were randomly
assigned at a 1:1 ratio to receive Xocova (375 mg on day 1 and 125 mg on days
2-5) or placebo, once daily, and began treatment within 72 hours of when the
household member with COVID-19 began showing symptoms. Participants then
continued Xocova (125 mg) or placebo for five days. SCORPIO-PEP is the first
and only Phase 3 study of an oral antiviral to meet the primary endpoint of
preventing COVID-19 following exposure to an infected individual.
https://en.wikipedia.org/wiki/Ensitrelvir
