Japan approves peadiatric dosage and New 25 mg tablet of XOCOVA for COVID-19 – Shionogi

Shionogi announced that it has received supplemental approval in Japan for the pediatric dosage and administration of XOCOVA (generic name: ensitrelvir fumaric acid; hereinafter “XOCOVA”), an anti-SARS-CoV-2 drug, for pediatric patients aged 6 to under 12 years who weigh at least 20 kg for the treatment of COVID-19. In addition, new, smaller 25 mg tablets have also been approved.

The approval is based on the results of a Phase 3 clinical trial conducted in pediatric patients aged 6 to under 12 years with SARS-CoV-2 infection weighing at least 20 kg in Japan. The trial evaluated the safety and pharmacokinetics of once-daily oral administration of XOCOVA for 5 days at weight-based doses, in a total of 117 participants. As a result, no new safety concerns were identified. Furthermore, the pediatric plasma concentration profiles of XOCOVA observed in the trial were confirmed to be comparable to those predicted for adults receiving therapeutic doses, based on a population pharmacokinetic (PPK) analysis. These findings support the appropriateness of the dosing regimen for children aged 6 to under 12 years.

COVID-19 remains a public health threat.2 With this approval, and in addition to its indication for adults and pediatric patients aged 12 years and older, XOCOVA becomes a new treatment option for pediatric patients aged 6 years and older weighing at least 20 kg, and is expected to contribute to the treatment of a broader pediatric population as an oral anti-SARS-CoV-2 drug that can be used regardless of risk factors for progression to severe disease.

Shionogi is committed to “Protect people worldwide from the threat of infectious diseases” as one of its key focuses, and is working toward the realization of total care for infectious diseases. Shionogi will continue to advance research and development in infectious diseases so that we can rapidly deliver the necessary therapeutics, prophylactics, and vaccines in response to the emergence of new variants and future epidemiological trends.

The impact of this matter on the consolidated financial results for the fiscal year ending March 2027 is expected to be minimal.

Product Information

Product name: XOCOVA Tablets 125 mg / XOCOVA Tablets 25 mg

Generic name: ensitrelvir fumaric acid

Indication: For the treatment and post-exposure prophylaxis of SARS-CoV-2 infection

Dosage and Administration:

〈Treatment〉

The usual dosage is the following amount of ensitrelvir, administered orally once daily.

Age group | Body weight | Dose | Day 1 dose | Days 2–5 dose
Adults and pediatric patients aged ≥12 years | ― | 375 mg | 125 mg
Pediatric patients aged 6 to <12 years | ≥40 kg | 375 mg | 125 mg
Pediatric patients aged 6 to <12 years | ≥30 kg to <40 kg | 250 mg | 125 mg
Pediatric patients aged 6 to <12 years | ≥20 kg to <30 kg* | 150 mg | 75 mg

• The 25 mg tablets have not yet been listed in the drug price.

〈post-exposure prophylaxis〉

For adults and pediatric patients aged 12 years and older, the usual dosage is 375 mg of ensitrelvir on Day 1, followed by 125 mg once daily on Days 2 to 5, administered orally.