Serelaxin for treating acute heart failure
 
Status Suspended
Process STA
Referral date 01 December 2013
Topic area
  • Cardiovascular
Description

Scoped as part of Batch 32

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

Timeline

Key events during the development of the guidance:

Date Update
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 how we develop guidance, please see our page about NICE technology appraisal guidance