Kantos Master - referral

Current status

European Commission final decision

Overview

On 17 January 2013, the European Medicines Agency completed an arbitration procedure for Kantos Master and associated names. The Agency's Committee for Medicinal Products for Human Use (CHMP) had been asked to arbitrate on a requested change to the marketing authorisation for these medicines to include a new use as rescue therapy for acute relief of asthma symptoms. The Committee concluded that the benefits of Kantos Master outweigh its risks in the new use and the change to the marketing authorisation can be granted in Germany and the following Member States: Austria, Belgium, Bulgaria, Cyprus, Denmark, Estonia, Finland, France, Greece, Hungary, Italy, Latvia, Lithuania, Luxembourg, the Netherlands, Norway, Poland, Romania, Slovenia, Spain, Sweden and the United Kingdom.

What is Kantos Master?

Kantos Master is a medicine that contains two active substances: beclomethasone dipropionate, a corticosteroid (a medicine that reduces inflammation), and formoterol fumarate, a bronchodilator (a medicine that opens the airways, allowing easier breathing) with a long duration of action.

Kantos Master is used as maintenance therapy in patients who have asthma. It is inhaled once or twice a day, in order to keep asthma under control and reduce symptoms. If patients develop symptoms of asthma (wheezing and difficulty breathing) inhalation of a separate bronchodilator medicine with a rapid onset and short duration of action is advised for relief (rescue therapy).

Kantos Master is marketed in all European Union (EU) Member States except the Czech Republic, Ireland, Malta, Portugal and Slovakia under the names Kantos, Formodual, Foster, Inuxair, Innovair and associated names. The company that makes the medicine is Chiesi.

Why was Kantos Master reviewed?

Kantos Master is authorised under a mutual-recognition procedure based on an initial authorisation granted by Germany. In December 2011, the company applied for an additional use in Germany. The company wanted the authorisation to be recognised in the following Member States: Austria, Belgium, Bulgaria, Cyprus, Denmark, Estonia, Finland, France, Greece, Hungary, Italy, Latvia, Lithuania, Luxembourg, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and the United Kingdom (the 'concerned Member States'). The application was for the use of Kantos Master for both maintenance therapy of asthma and for relief of symptoms when they arise instead of the use of a separate short-acting bronchodilator (maintenance and reliever therapy, or MART).

However, the Member States were unable to reach agreement on whether to accept this indication for Kantos Master. On 13 December 2012, Germany referred the matter to the CHMP for arbitration.

The grounds for the referral were the concerns of Sweden that the data on Kantos Master submitted in the application were not sufficient to demonstrate its effectiveness for MART. In particular, in the main study comparing the use of Kantos Master for MART versus maintenance treatment with Kantos Master plus a short-acting bronchodilator given for relief, there were concerns that the comparison group might not have been receiving adequate maintenance treatment, which could have made the results in the MART group look better than they really were.

What are the conclusions of the CHMP?

The Committee looked at the study presented by the company to support its application.

Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP agreed that Kantos Master has been shown to reduce the risk of severe exacerbation of asthma and prolong the time between exacerbations when part of the dose is given on an as-needed basis as MART. The CHMP noted that MART was not compared with the standard of care according to current guidelines, but agreed that there was no evidence that patients in the comparison group had been undertreated, as patients in both groups had shown clinical benefit from their maintenance treatment. It also took note of relevant literature supporting the principle of using such a combination of corticosteroid and long-acting bronchodilator (beclometasone and formoterol) for MART.

The CHMP therefore concluded that the benefits of Kantos Master for MART outweigh its risks and recommended that the marketing authorisation be granted in Germany and the concerned Member States.

The European Commission issued a decision on 10 April 2013.

Questions and answers on Kantos Master and associated names (beclomethasone dipropionate / formoterol fumarate, inhaler)

Key facts

About this medicine

• Approved name:
  Kantos Master
• International non-proprietary name (INN) or common name:
  • beclometasone dipropionate
  • formoterol fumarate
• Associated names:
  • Kantos
  • Formodual
  • Foster
  • Inuxair
  • Innovair and associated names
• Class:
  -

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/H/A-13/1350
• Type:
  Article 13 referrals

  This type of referral is triggered for a medicine that has been authorised by mutual recognition or via the decentralised procedure when there is disagreement between Member States on a variation (type II), on the grounds of a potential serious risk to public health.

Key dates and outcomes

• CHMP opinion date:
  17/01/2013
• EC decision date:
  10/04/2013

All documents

Opinion provided by Committee for Medicinal Products for human Use

Questions and answers on Kantos Master and associated names (beclomethasone dipropionate / formoterol fumarate, inhaler)

European Commission final decision

Kantos Master Article-13 referral - Assessment report

Adopted Reference Number: EMA/210436/2013

Kantos Master Article-13 referral - Annex I

Kantos Master Article-13 referral - Annex II

Kantos Master Article-13 referral - Annex III

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.