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news.Italy-based pharmaceutical firm Recordati has received approval for its antihypertensive Zanitek, a fixed combination of lercanidipine and enalapril, from the German medicines agency, BfArM.
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Most hypertensive patients, especially those with other associated risk factors, now require multiple therapies using more than one drug to keep their blood pressure at desired levels. Fixed combinations of more than one antihypertensive agent are, therefore, expected to play a significant and increasing role in the future of the hypertension market.
The potential advantages of fixed combinations are significant. The drugs used have already proven their efficacy and tolerability in clinical trials, while the reduction of the number of pills a patient must take, especially in the elderly, increases patient compliance.
“This is a very important achievement for our group,” stated Giovanni Recordati, Recordati chairman and CEO. “The importance for our group of Zanitek, a modern drug which meets the needs of both patients and medical practitioners, cannot be underestimated and we expect a sequence of launches in the main European markets.”
Germany will act as reference member state in the mutual recognition approval process for the rest of Europe, which is expected to be completed during 2007.