Approval based on Phase 3 trial in 117 children showing a 5‑day once‑daily regimen is safe with pediatric PK similar to adults, supporting weight‑based dosing. The approval expands XOCOVA to include pediatric patients 6 years and older who weigh at least 20 kg and introduces 25 mg tablets. Impact on the company’s fiscal year 2027 results is expected to be minimal.

Shionogi Announces Supplemental Approval in Japan for Pediatric Dosage and Administration of XOCOVA® to Treat COVID-19

The U.S. Food and Drug Administration has approved Shionogi's Xocova (ensitrelvir), an oral antiviral, for postexposure prophylaxis (PEP) of COVID‑19 in adults and adolescents aged 12 years and older.

FDA approves Xocova for COVID-19 postexposure prophylaxis

Shionogi said on June 1 that its COVID-19 drug Xocova (ensitrelvir) gained approval from the US FDA for the prevention of COVID-19 following exposure to SARS-CoV-2.

Shionogi’s Xocova Scores US FDA Nod for COVID-19 PEP

Shionogi Announces FDA Approval of XOCOVA® (ensitrelvir), the First and Only Oral Option to Help Prevent COVID-19 Following Exposure.

Shionogi Announces FDA Approval of XOCOVA® (ensitrelvir), the First and Only Oral Option to Help Prevent COVID-19 Following Exposure

Ansun Biopharma, Inc., a clinical-stage biopharmaceutical company, today announced that its independent Data Monitoring Committee (DMC) has issued a positive recommendation following a prespecified interim efficacy and safety review of the Company's Phase 3 clinical trial (DAS181-3-01). DAS181 is being evaluated for the treatment of parainfluenza pneumonia infection in immunocompromised patients requiring oxygen support.

Ansun Biopharma Announces Independent Data Monitoring Committee Recommendation Supporting Continued Phase 3 Development of DAS181 in Immunocompromised Patients with Parainfluenza Infection

Japan's Shionogi on Monday said it won FDA approval for its oral antiviral to prevent Covid‑19 in adults and children older than 12 years who have been in contact with someone ...

Shionogi wins US approval for first pill to prevent Covid following exposure

After a prior misfire in demonstrating its protease inhibitor ensitrelvir’s potential as a COVID-19 treatment for U.S. patients, Shionogi has secured an FDA green light for the medicine in the prevention setting.

Shionogi's COVID antiviral Xocova passes muster with FDA as post-exposure preventative

Japan's Shionogi & Co said on Monday ⁠the U.S. Food and Drug Administration has approved ⁠its oral antiviral Ensitrelvir, commercially known as ⁠Xocova, for the...    Reuters Health Information

US Regulator Approves Oral Drug From Japan's Shionogi to Prevent COVID-19

The FDA approved the oral antiviral agent ensitrelvir (Xocova) to help prevent COVID-19 in people ages 12 years or older who were exposed to the SARS-CoV-2 virus, drugmaker Shionogi announced.

FDA Approves Oral Antiviral to Prevent COVID-19 After Exposure

The U.S. Food and Drug Administration in White Oak, Md., on June 5, 2023. (Madalina Vasiliu/The Epoch Times)

antiviral news

Press Releases in the global landscape