Novartis announced that European regulators adopted a positive opinion for Rasilamlo, which combines the company's Tekturna (aliskiren) with amlodipine, to treat patients with hypertension not adequately controlled by the drug's individual components.
The positive recommendation was based on results from clinical trials involving more than 5000 patients with mild-to-moderate high blood pressure, which showed that treatment with Rasilamlo resulted in greater reductions in systolic and diastolic blood pressure compared to Tekturna or amlodipine alone. The combination product was approved in the US last year under the name Tekamlo.
Reference Articles
CHMP summary of positive opinion for Rasilamlo - (EMA)
EU drugs agency backs Novartis blood pressure drug - (London South East)
Novartis Receives Positive CHMP Opinion For Rasilamlo - (Stock Markets Review)
Novartis gains positive CHMP opinion for Rasilamlo, a single-pill combination of aliskiren and amlodipine to treat high blood pressure - (Trading Markets)
European committee OKs Novartis drug Rasilamlo - (Yahoo!Finance)
**published in "First Word"
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