Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 September 2012

Summary of opinion for Constella

Press release: European Medicines Agency recommends authorisation of first medicine specifically for irritable bowel syndrome

Summary of opinion for NexoBrid

Press release: European Medicines Agency recommends first medical treatment for removal of eschar from severe burn wounds

Trajenta is indicated in the treatment of type-2 diabetes mellitus to improve glycaemic control in adults:

• as monotherapy:
  • in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to intolerance, or contraindicated due to renal impairment;
• as combination therapy:
  • in combination with metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control;
  • in combination with a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control;
  • in combination with insulin with or without metformin, when this regimen alone, with diet and exercise, does not provide adequate glycaemic control.

Renal angiomyolipoma associated with tuberous sclerosis complex (TSC)

Votubia is indicated for the treatment of adult patients with renal angiomyolipoma associated with tuberous sclerosis complex (TSC) who are at risk of complications (based on factors such as tumour size or presence of aneurysm, or presence of multiple or bilateral tumours) but who do not require immediate surgery.

The evidence is based on analysis of change in sum of angiomyolipoma volume.

Subependymal giant cell astrocytoma (SEGA) associated with TSC.

Votubia is indicated for the treatment of patients aged 3 years and older with SEGA associated with TSC who require therapeutic intervention but are not amenable to surgery.

The evidence is based on analysis of change in SEGA volume. Further clinical benefit, such as improvement in disease-related symptoms, has not been demonstrated.

Vildagliptin / metformin hydrochloride is indicated in the treatment of type-2 diabetes mellitus:

• in the treatment of adult patients who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone or who are already treated with the combination of vildagliptin and metformin as separate tablets;
• in combination with a sulphonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled with metformin and a sulphonylurea;
• in triple combination therapy with insulin as an adjunct to diet and exercise to improve glycaemic control in patients when insulin at a stable dose and metformin alone do not provide adequate glycaemic control.

Summary of opinion for Eucreas

Summary of opinion for Icandra

Summary of opinion for Zomarist

Vildagliptin is indicated in the treatment of type-2 diabetes mellitus in adults:

• as monotherapy:
  • in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance;
• as dual oral therapy in combination with:
  • metformin, in patients with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin;
  • a sulphonylurea, in patients with insufficient glycaemic control despite maximal tolerated dose of a sulphonylurea and for whom metformin is inappropriate due to contraindications or intolerance;
  • a thiazolidinedione, in patients with insufficient glycaemic control and for whom the use of a thiazolidinedione is appropriate;
• as triple oral therapy in combination with:
  • a sulphonylurea and metformin when diet and exercise plus dual therapy with these agents do not provide adequate glycaemic control.

Vildagliptin is also indicated for use in combination with insulin (with or without metformin) when diet and exercise plus a stable dose of insulin do not provide adequate glycaemic control.

Summary of opinion for Galvus

Summary of opinion for Jalra

Summary of opinion for Xiliarx

• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
• Second- or third-degree atrioventricular block, complete bundle branch block, distal block, sinus node dysfunction, atrial conduction defects, or sick sinus syndrome (except when used in conjunction with a functioning pacemaker).
• Bradycardia 50 beats per minute (bpm).
• Permanent atrial fibrillation (AF) with an AF duration ≥6 months (or duration unknown) and attempts to restore sinus rhythm no longer considered by the physician.
• Patients in unstable haemodynamic conditions.
• History of or current heart failure or left ventricular systolic dysfunction.
• Patients with liver and lung toxicity related to the previous use of amiodarone.
• Co-administration with potent cytochrome P450 (CYP) 3A4 inhibitors, such as ketoconazole, itraconazole, voriconazole, posaconazole, telithromycin, clarithromycin, nefazodone and ritonavir.
• Medicinal products inducing torsades de pointes such as phenothiazines, cisapride, bepridil, tricyclic antidepressants, terfenadine and certain oral macrolides (such as erythromycin), class I and III antiarrhythmics.
• QTc Bazett interval ≥500 milliseconds.
• Severe hepatic impairment.
• Severe renal impairment (CrCl 30 ml/min).
• Co-administration with dabigatran