Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 January 2013

Summary of opinion for Jetrea

Press release: European Medicines Agency recommends approval of medicine for treatment of vitreomacular traction

Polyarticular juvenile idiopathic arthritis

Humira in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in children and adolescents aged 2 to 17 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). Humira can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5.1). Humira has not been studied in children aged less than 2 years.

Detailed conditions 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 the variation to the marketing authorisation has been granted by the European Commission.

Cryopyrin-associated periodic syndromes

Ilaris is indicated for the treatment of cryopyrin-associated periodic syndromes (CAPS) in adults, adolescents and children aged 2 years and older with body weight of 7.5 kg or above, including:
- Muckle-Wells syndrome (MWS);
- neonatal-onset multisystem inflammatory disease (NOMID) / chronic infantile neurological, cutaneous, articular syndrome (CINCA), severe forms of familial cold auto-inflammatory syndrome (FCAS) / familial cold urticaria (FCU) presenting with signs and symptoms beyond cold-induced urticarial skin rash.

Gouty arthritis

Ilaris is indicated for the symptomatic treatment of adult patients with frequent gouty arthritis attacks (at least three attacks in the previous 12 months) in whom non-steroidal anti-inflammatory drugs (NSAIDs) and colchicine are contra-indicated, are not tolerated, or do not provide an adequate response, and in whom repeated courses of corticosteroids are not appropriate (see section 5.1).

Komboglyze is indicated as an adjunct to diet and exercise to improve glycaemic control in adult patients aged 18 years and older with type-2 diabetes mellitus inadequately controlled on their maximally tolerated dose of metformin alone or those already being treated with the combination of saxagliptin and metformin as separate tablets.

Komboglyze is also indicated in combination with insulin (i.e. triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in adult patients aged 18 years and older with type-2 diabetes mellitus when insulin and metformin alone do not provide adequate glycaemic control.

Komboglyze is also indicated in combination with a sulphonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in adult patients aged 18 years and older with type-2 diabetes mellitus when the maximally tolerated dose of both metformin and the sulphonylurea does not provide adequate glycaemic control.

Onglyza is indicated in adult patients aged 18 years and older with type-2 diabetes mellitus to improve glycaemic control:

- as dual oral therapy in combination with:

- metformin, when metformin alone, with diet and exercise, does not provide adequate glycaemic control;
- a sulphonylurea, when the sulphonylurea alone, with diet and exercise, does not provide adequate glycaemic control. in patients for whom use of metformin is considered inappropriate;
- a thiazolidinedione, when the thiazolidinedione alone with diet and exercise, does not provide adequate glycaemic control in patients for whom use of a thiazolidinedione is considered appropriate;

- as triple oral therapy in combination with:

- metformin plus a sulphonylurea when this regimen alone, with diet and exercise, does not provide adequate glycaemic control;

- as combination therapy with insulin (with or without metformin), when this regimen alone, with diet and exercise, does not provide adequate glycaemic control.

Paediatric patients five years of age and older

Pegasys in combination with ribavirin is indicated for the treatment of chronic hepatitis C in treatment-naïve children and adolescents five years of age and older, who are positive for serum hepatitis-C-virus (HCV) RNA.

When deciding to initiate treatment in childhood, it is important to consider growth inhibition induced by combination therapy. The reversibility of growth inhibition is uncertain. The decision to treat should be made on a case-by-case basis (see section 4.4).

European Medicines Agency confirms recommendation to suspend Tredaptive, Pelzont and Trevaclyn