For information, the company reported that the THRIVE-131 Phase III trial did not meet its primary endpoint and have advised that they will not be submitting a Marketing Authorisation Application to the Medicines and Healthcare products Regulatory Agency (MHRA) for this indication. Therefore, NICE has decided to suspend this appraisal from its current work programme. As this appraisal has been referred NICE will continue to monitor any development and will update interested parties if the situation changes.
- Status:
- Suspended
- Technology type:
- Medicine
- Decision:
- Selected
- Reason for decision:
- Anticipate the topic will be of importance to patients, carers, professionals, commissioners and the health of the public to ensure clinical benefit is realised, inequalities in use addressed, and help them make the best use of NHS resources
- Process:
- STA Standard
- ID number:
- 6551
Email enquiries
If you have any queries please email topic.selection@nice.org.uk
Related links
Timeline
Key events during the development of the guidance:
| Date | Update |
|---|---|
| 20 October 2025 | Suspended. For information, the company reported that the THRIVE-131 Phase III trial did not meet its primary endpoint and have advised that they will not be submitting a Marketing Authorisation Application to the Medicines and Healthcare products Regulatory Agency (MHRA) for this indication. Therefore, NICE has decided to suspend this appraisal from its current work programme. As this appraisal has been referred NICE will continue to monitor any development and will update interested parties if the situation changes. |
| 02 October 2025 | To appraise the clinical and cost effectiveness of Inclacumab within its marketing authorisation for treating sickle cell disease ID6551 |
| 07 February 2025 | Awaiting development. Status change linked to Topic Selection Decision being set to Selected |
For further information on our processes and methods, please see our CHTE processes and methods manual