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German Approval Received for Zanitek(R) (Lercanidipine/Enalapril), New Lercanidipine Based Product
MILAN, ITALY -- July 27, 2006 -- Recordati announced that it has received the approval for its new product ZanitekŪ, a fixed combination of lercanidipine and enalapril, from the BfArM, the German medicines agency. 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.
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 will therefore play a significant and increasing role in the future hypertension market. The advantages of fixed combinations as opposed to the administration of separate treatments are significant.
The combined dosages of the drugs are those broadly used by the physician and their efficacy and tolerability have been proven in clinical trials. The reduction of the number of pills a patient must take, especially in the elderly, increases patient compliance - which is extremely important in chronic treatments aimed at reducing and preventing cardiovascular risk.
"This is a very important achievement for our Group and confirms the effectiveness of our research activities and our regulatory capabilities in Europe", stated Giovanni Recordati, Chairman and CEO. "Sales of lercanidipine already account for 30% of our pharmaceutical revenues. Even after a number of years from its launch our product continues to improve its performance in the main international markets. Sales of lercanidipine in the first half 2006 increased by more than 25% over the same period of the preceding year. The importance for our group of ZanitekŪ, 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."
SOURCE: Recordati SpA
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