14 April 2008 - Boehringer Ingelheim today announced that the European Commission has granted marketing authorisation of the new powerful strength of their fixed dose combination antihypertensive drug MicardisPlus® 80/25 in all 27 EU member states. It will be launched in Germany and Denmark in the coming weeks, followed soon by Ireland, the United Kingdom and the rest of EU, and when approved also in other countries around the world.
The product is licensed for the treatment of essential hypertension in patients whose blood pressure is not adequately controlled on MicardisPlus® 80/12.5 (80 mg telmisartan/12.5 mg hydrochlorothiazide) or patients who have been previously stabilized on telmisartan and hydrochlorothiazide separately at the same dosages. 1,2
The new strength will be marketed by Boehringer Ingelheim in all 27 countries of the European Union under the brand name MicardisPlus® 80/25. It’s co-marketing partners will market the new drug in selected countries under their own brands.
“The approval of MicardisPlus® 80/25 provides physicians with a powerful new drug for patients with difficult to treat essential hypertension“, said Dr Andreas Barner, Member of the Board of Boehringer Ingelheim and responsible for Research, Development and Medicine.
European approval of MicardisPlus® 80/25 follows the submission of efficacy and safety data from 12 clinical trials performed in patients with mild to moderate hypertension. The core clinical development programme consisted of two consecutive trials designed to demonstrate the superiority of the fixed dose combination 80 mg telmisartan/25 mg hydrochlorothiazide (T80/H25) versus 80 mg telmisartan/12.5 mg hydrochlorothiazide (T80/H12.5).2 971 patients, who were inadequately controlled for their blood pressure (BP) on existing antihypertensive treatment, were enrolled in the programme. Treatment with T80/H25 provided superior diastolic and systolic blood pressure lowering power after 8 weeks of treatment1 compared to T80/H12.5. In the consecutive follow up trial 639 patients (633 patients evaluated for efficacy) were treated with the T80/H25 for further 6 months. At the end of this treatment interval the proportion of patients achieving DBP control had increased from 52.4% to 71.4%.2
No clinically meaningful differences in the adverse event profiles of T80/H25 and T80/H12.5 were detected. No specific increased incidence was identified for all adverse events. No additional specific safety issues have been identified1,2. Other studies considered by the EMEA showed clearly superior clinical benefits for a T80/H25-based treatment compared with 160 mg valsartan /25 mg hydrochlorothiazide, the market leading ARB´s high strength combination.
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