For information, the company has decided not to submit a Marketing Authorization Application in Europe based on the following topline data: • The two induction cohorts missed the co-primary endpoints of clinical remission and endoscopic response at Week 10. • In the maintenance phase, filgotinib 200mg once daily achieved the co-primary endpoints of clinical remission and endoscopic response at Week 58. • The safety findings were generally consistent with the known profile of filgotinib in rheumatoid arthritis (RA) and ulcerative colitis (UC). 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 TA
ID number 6236

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Timeline

Key events during the development of the guidance:

Date Update
15 March 2023 Suspended. For information, the company has decided not to submit a Marketing Authorization Application in Europe based on the following topline data: • The two induction cohorts missed the co-primary endpoints of clinical remission and endoscopic response at Week 10. • In the maintenance phase, filgotinib 200mg once daily achieved the co-primary endpoints of clinical remission and endoscopic response at Week 58. • The safety findings were generally consistent with the known profile of filgotinib in rheumatoid arthritis (RA) and ulcerative colitis (UC). 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.
18 January 2023 Awaiting development. Status change linked to Topic Selection Decision being set to Selected

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