This month the CHMP adopted positive opinions for the following medicines:
- Regeneron’s Arcalyst (rilonacept) for the treatment of adults and children aged 12 years and older with severe symptoms of Cryopyrin-Associated Periodic Syndromes (CAPS)
- Novartis Europharm’s Exforge HCT (amlodipine besylate/valsartan/hydrochlorothiazide), Copalia HCT (amlodipine besylate/valsartan/hydrochlorothiazide), Imprida HCT (amlodipine besylate/valsartan/hydrochlorothiazide) and Dafiro HCT (amlodipine besylate/valsartan/hydrochlorothiazide), all for the treatment of essential hypertension
- Novartis Europharm’s Ilaris (canakinumab) for the treatment of adults, adolescents and children aged 4 years and older with Cryopyrin-Associated Periodic Syndromes (CAPS)
- Ratiopharm’s Ratioepo (epoetin theta) and Eporatio (epoetin theta), and CT Arzneimittel’s Biopoin (epoetin theta) for the treatment of symptomatic anaemia associated with chronic renal failure and in adult cancer patients with non-myeloid malignancies receiving chemotherapy
- Movetis’ Resolor (prucalopride) for chronic constipation in women.
The following generic medicines were also recommended for marketing authorisation:
- Enyglid (repaglinide) and Repaglinide Krka (repaglinide) from Krka DD Novo Mesto, generics of Novonorm, for type 2 diabetes
- Irbesartan Teva (irbesartan), a generic of Aprovel, for essential hypertension
- Lamivudine Teva (lamivudine), a generic of Zeffix, for chronic hepatitis B in adults
- Clopidogrel MYLAN Pharma (clopidogrel, as besilate), a generic of Plavix, for the prevention of atherothrombotic events in patients suffering from myocardial infarction or established peripheral arterial disease.
The Committee gave positive opinions for new treatment options for the following medicines:
- MSD’s Isentress (raltegravir), to extend the indication to include antiretroviral treatment naïve adult patients
- UCB’s Keppra (levetiracetam), to extend the use of the medicine to children and infants for the adjunctive treatment of partial seizures (fits) with or without secondary generalisation
- Roche’s Mabthera (rituximab), to include the treatment of relapsed/refractory chronic lymphocytic leukaemia
- Wyeth’s Torisel (temsirolimus), to include adult patients with relapsed and/or refractory mantle cell lymphoma.