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news.Novartis's Diovan has been granted pediatric exclusivity by the FDA based on studies conducted in children with high blood pressure. This action extends marketing exclusivity associated with Novartis's valsartan compound patent by six months, to September 2012.
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Although high blood pressure is more prevalent in adults, Novartis says that it has been reported that nearly 5% of children and adolescents in the US may have the condition.
An FDA decision on a possible indication to treat children and adolescents with high blood pressure is anticipated by the end of the year.
“Novartis feels that wherever possible it is important to ensure that medications are studied in patient groups usually excluded from general clinical trials, such as younger people,” said Dr James Shannon, global head of development at Novartis.
Diovan is the only agent in its class (angiotensin receptor blockers, or ARBs) indicated to treat adults not only with high blood pressure, but also heart failure, as well as heart attack survivors.
The drug specifically blocks a hormone that causes arteries to constrict, an action that can cause high blood pressure.