Cubicin

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Questions & Answers

On 12 October 2017, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Cubicin. The marketing authorisation holder for this medicinal product is Merck Sharp & Dohme Limited.

The CHMP adopted an extension to an existing indication to include treatment of1:

Adult and paediatric (1 to 17 years of age) patients with Staphylococcus aureus bacteraemia (SAB) when associated with RIE or with cSSTI. In adults, use in bacteraemia should be associated with RIE or with cSSTI, while in paediatric patients, use in bacteraemia should be associated with cSSTI.

For information, the full indications for Cubicin will be as follows:

“Cubicin is indicated for the treatment of the following infections (see sections 4.4 and 5.1).

  • Adult and paediatric (1 to 17 years of age) patients with complicated skin and soft-tissue infections (cSSTI).
  • Adult patients with right-sided infective endocarditis (RIE) due to Staphylococcus aureus. It is recommended that the decision to use daptomycin should take into account the antibacterial susceptibility of the organism and should be based on expert advice. See sections 4.4 and 5.1.
  • Adult and paediatric (1 to 17 years of age) patients with Staphylococcus aureus bacteraemia (SAB). In adults, use in bacteraemia should be associated with RIE or with cSSTI, while in paediatric patients, use in bacteraemia should be associated with cSSTI.

Daptomycin is active against Gram positive bacteria only (see section 5.1). In mixed infections where Gram negative and/or certain types of anaerobic bacteria are suspected, Cubicin should be co-administered with appropriate antibacterial agent(s).

Consideration should be given to official guidance on the appropriate use of antibacterial agents.”

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.


1 New text in bold, removed text as strikethrough

Name Language First published Last updated
CHMP post-authorisation summary of positive opinion for Cubicin (II-61) (English only) 2017-10-13  

Key facts

Product details for Cubicin
NameCubicin
INN or common name

daptomycin

Therapeutic area Gram-Positive Bacterial InfectionsSoft Tissue InfectionsEndocarditis, BacterialBacteremia
Active substance

daptomycin

Date opinion adopted12/10/2017
Company name

Merck Sharp & Dohme Limited

StatusPositive
Application typePost authorisation