Mysimba - referral

Current status

Under evaluation

Overview

EMA has started a review of Mysimba (naltrexone / bupropion), a medicine for weight management in adults who have obesity or are overweight. The medicine is recommended for use in addition to diet and exercise.

The review of Mysimba was prompted by remaining concerns regarding the potential long-term cardiovascular risk (affecting the heart and blood circulation) with Mysimba and its impact on the benefit-risk balance of the medicine.

Uncertainties regarding the long-term effects of Mysimba on the cardiovascular system were noted at the time of Mysimba’s authorisation. Two studies evaluating cardiovascular risk with this medicine were stopped before completion, and a third study was therefore required to comply with the conditions of the marketing authorisation.

At the time of the review, the third study to evaluate the potential cardiovascular risk with the medicine had not yet started and EMA’s human medicines committee (CHMP) considered study designs proposed by the marketing authorisation holder (MAH) insufficient to investigate long-term cardiovascular safety. In addition, risk minimisation measures proposed by the MAH to mitigate the potential risk in patients receiving long-term treatment with Mysimba were not considered sufficient to overcome the need for a study.

EMA will now assess all available data on the potential long-term cardiovascular safety risk and its impact on the benefit-risk balance of Mysimba in its approved indication and recommend whether the medicine’s marketing authorisation in the EU should be amended, suspended or revoked.

More about the medicine

Mysimba is a medicine used along with diet and exercise to help manage weight in adults who have obesity (have a body-mass index - BMI - of 30 or more) or who are overweight (have a BMI between 27 and 30) and have weight-related complications such as diabetes, abnormally high levels of fat in the blood, or high blood pressure. It was granted marketing authorisation on 26 March 2015.

More about the procedure

The review of Mysimba has been initiated at the request of the European Commission, under Article 20 of Regulation (EC) No 726/2004.

The review is being carried out by the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which will adopt the Agency’s opinion. The CHMP opinion will then be forwarded to the European Commission, which will issue a final legally binding decision applicable in all EU Member States.

Mysimba Article-20 procedure - EMA starts review of weight management medicine Mysimba

Reference Number: EMA/406052/2023

Key facts

About this medicine

• Approved name:
  Mysimba
• International non-proprietary name (INN) or common name:
  • naltrexone
  • bupropion
• Associated names:
  Mysimba

About this procedure

• Current status:
  Under evaluation
• Reference number:
  EMEA/H/A-20/1530/C/3687/0065
• Type:
  Article 20 procedures

  This type of procedure is triggered for medicines that have been authorised via the centralised procedure in case of quality, safety or efficacy issues.

• Authorisation model:
  Centrally authorised product(s)
• Decision making model:
  CHMP-EC

All documents

Procedure started

Mysimba Article-20 procedure - Notification

Mysimba Article-20 procedure - EMA starts review of weight management medicine Mysimba

Reference Number: EMA/406052/2023

Under evaluation

Mysimba Article-20 procedure - CHMP List of questions

Reference Number: EMA/CHMP/236208/2024

Mysimba Article-20 procedure - Timetable for the procedure

Reference Number: EMA/CHMP/352892/2023 Rev.5

Description of documents published

Please note that some of the listed documents apply only to certain procedures.

• Overview - lay-language summary of the stage of the procedure
• Notification – a letter from a Member State, the European Commission or the marketing authorisation holder requesting the initiation of the procedure
• Scientific background – further background information from the triggering Member State on the issues leading to the initiation of the procedure (if applicable)
• List of questions – questions agreed by the Committee requesting further information from the marketing authorisation holder(s) / applicant(s) to evaluate the issues identified
• Timetable for the procedure – agreed timeframe to respond to the list of questions, to assess the issues and to adopt a conclusion
• List of medicines concerned by the procedure – medicine(s) / active substance(s) concerned, and marketing authorisation holder(s) / applicant(s)
• List of questions to be addressed by the stakeholders – call for data to be submitted by stakeholders (e.g. healthcare professionals, patient organisations, individual patients) (if applicable)
• Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
• Scientific conclusions – scientific conclusions of the PRAC and/or CHMP and/or CMDh
• Assessment report – PRAC or CHMP assessment and conclusions on the issues investigated, including divergent positions (if applicable)
• Divergent positions – divergent positions of the CHMP or CMDh members for pharmacovigilance procedures (if applicable)
• Changes to the summary of product characteristics, labelling and package leaflet (amended sections or fully revised version) (if applicable)
• Condition(s) to the marketing authorisation(s) – condition(s) for the safe and effective use of the medicine(s) (if applicable)
• Condition for lifting the suspension – condition to be fulfilled for the suspension of the marketing authorisation(s) to be lifted (if applicable)
• Timetable for implementation of CMDh position – agreed timeframe to submit and finalise the variation(s) implementing the outcome of the procedure (if applicable)

Note that older documents may have different titles.