Two Bayer hypertension drugs receive further marketing approval in EU

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Bayer Schering Pharma was granted European marketing authorization for its new antihypertensive fixed dose combination drugs PritorPlus 80/25 and Kinzalkomb 80/25 (80 mg telmisartan/25 mg hydrochlorothiazide) by the European Commission.

The new formulations were launched in Germany in April, to be followed by selected countries in the EU, the Berlin-based Bayer said.

The company said that the products are indicated for the treatment of essential hypertension in patients whose blood pressure is not adequately controlled on PritorPlus 80/12.5 and Kinzalkomb 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.

Bayer said that the European approval of PritorPlus 80/25 and Kinzalkomb 80/25 follows the submission of efficacy and safety data from 12 clinical trials performed in patients with mild to moderate hypertension.