Baloxavir marboxil appraisal terminated for children
Summary
NICE has terminated the appraisal of baloxavir marboxil for treating and preventing influenza in children aged 1 to 11 years. The decision was made because the company failed to provide an evidence submission for the technology appraisal.
What changed
NICE has terminated its appraisal of baloxavir marboxil (Xofluza) for the treatment and prevention of influenza in children aged 1 to 11 years. The appraisal was terminated because the pharmaceutical company did not submit the required evidence for review. This means no recommendation will be made for the use of this drug in this pediatric population under the technology appraisal process.
This termination means that healthcare providers and patients will not receive a NICE recommendation for baloxavir marboxil for this specific indication. Drug manufacturers seeking approval or recommendation for new treatments should ensure timely and complete evidence submissions to regulatory bodies like NICE. The decision may be revisited if the company decides to make a future submission.
What to do next
- Note the termination of the NICE appraisal for baloxavir marboxil in children aged 1-11 years.
- Inform relevant clinical teams that no NICE recommendation will be issued for this indication.
Source document (simplified)
Baloxavir marboxil for treating and preventing influenza in children 1 to 11 years (terminated appraisal)
- Technology appraisal
- TA1135
- Published:
19 February 2026
Overview
NICE is unable to make a recommendation on baloxavir marboxil (Xofluza) for treating and preventing influenza in children 1 to 11 years. This is because the company did not provide an evidence submission.
Last reviewed: 19 February 2026
Next review: We will review this decision if the company decides to make a submission.
Guidance development process
Related changes
Source
Classification
Who this affects
Taxonomy
Browse Categories
Get Drug Safety alerts
Weekly digest. AI-summarized, no noise.
Free. Unsubscribe anytime.
Get alerts for this source
We'll email you when NICE Technology Appraisals publishes new changes.