Project information | Serelaxin for the treatment of acute decompensated heart failure [ID673] | Guidance

Serelaxin for treating acute heart failure

Following on from information provided to NICE by the company in July 2014 the appraisal of Serelaxin for the treatment of acute decompensated heart failure [ID673] was suspended from NICE’s work programme. As no further information has been received from the company the topic has been discontinued.

Status	Discontinued
Technology type	Medicine
Decision	Selected
Process	TA
ID number	673
Referral date	01 December 2013
Topic area	Cardiovascular

Provisional Schedule

Closing date for invited submissions / evidence submission:	TBC
1st appraisal committee meeting:	TBC

Project Team

Communications manager:	TBC
Executive Lead:	TBC
Project manager:	TBC
Technical Lead:	TBC

Email enquiries

If you have any queries please email scheduling@nice.org.uk

Timeline

Key events during the development of the guidance:

Date	Update
19 January 2023	Discontinued. Following on from information provided to NICE by the company in July 2014 the appraisal of Serelaxin for the treatment of acute decompensated heart failure [ID673] was suspended from NICE’s work programme. As no further information has been received from the company the topic has been discontinued.
03 July 2014	On 23 January 2014, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for serelaxin. Following a re-examination of the opinion, at the request of the applicant, a further refusal of the marketing authorisation was given on 22 May 2014. Therefore, the appraisal of serelaxin for treating acute heart failure has been suspended indefinitely on the technology appraisals work programme. For information, we note that the manufacturer is conducting an additional phase III clinical trial and intends to re-submit for marketing authorisation in the future, therefore, we will continue to monitor the situation and will update interested parties if and when the situation changes.
24 April 2014	As you will be aware, the Department of Health has asked the Institute to conduct an appraisal of serelaxin for treating acute heart failure. Following an update on the regulatory status of this technology, which has received a negative CHMP opinion, the manufacturer has now informed us that they have submitted a re-examination application for serelaxin. We are therefore monitoring this situation and will provide an update as soon as possible.

Date

Update

19 January 2023

Discontinued. Following on from information provided to NICE by the company in July 2014 the appraisal of Serelaxin for the treatment of acute decompensated heart failure [ID673] was suspended from NICE’s work programme. As no further information has been received from the company the topic has been discontinued.

03 July 2014

On 23 January 2014, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for serelaxin. Following a re-examination of the opinion, at the request of the applicant, a further refusal of the marketing authorisation was given on 22 May 2014.

Therefore, the appraisal of serelaxin for treating acute heart failure has been suspended indefinitely on the technology appraisals work programme.

For information, we note that the manufacturer is conducting an additional phase III clinical trial and intends to re-submit for marketing authorisation in the future, therefore, we will continue to monitor the situation and will update interested parties if and when the situation changes.

24 April 2014

As you will be aware, the Department of Health has asked the Institute to conduct an appraisal of serelaxin for treating acute heart failure.

Following an update on the regulatory status of this technology, which has received a negative CHMP opinion, the manufacturer has now informed us that they have submitted a re-examination application for serelaxin.

We are therefore monitoring this situation and will provide an update as soon as possible.

For further information on our processes and methods, please see our CHTE processes and methods manual