Two Bayer hypertension drugs receive further marketing approval in EU
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.
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.