For information, the company have announced that phase 2 HIMALAYA study did not meet its primary endpoint in ALSFRS-R and therefore they will no longer be pursuing a Marketing Authorisation Application in this indication at this time.
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 as and when 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 | 6385 |
Email enquiries
- If you have any queries please email scheduling@nice.org.uk
Timeline
Key events during the development of the guidance:
| Date | Update |
|---|---|
| 22 April 2024 | Suspended. For information, the company have announced that phase 2 HIMALAYA study did not meet its primary endpoint in ALSFRS-R and therefore they will no longer be pursuing a Marketing Authorisation Application in this indication at this time. 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 as and when the situation changes. |
| 22 April 2024 | Awaiting development. Appraisal suspended |
| 29 November 2023 | Awaiting development. Status change linked to Topic Selection Decision being set to Selected |
| 29 November 2023 | Topic selection |
For further information on our processes and methods, please see our CHTE processes and methods manual