15 November 2017 - Noden Pharma announced today the approval by the U.S. FDA of Tekturna (aliskiren) oral pellets for the treatment of hypertension in adults and children six years of age and older. The new formulation and paediatric indication were approved through the FDA priority review process. 

Noden Pharma is a wholly-owned subsidiary of PDL BioPharma.

The efficacy and safety of Tekturna for paediatric use was evaluated in an 8-week randomised, double-blind trial in 267 hypertensive patients 6 to 17 years of age, including 208 patients treated for 52 weeks, following the 8-week study. During the initial dose-response phase, Tekturna reduced both systolic and diastolic blood pressure in a weight-based dose-dependent manner. These studies did not reveal any unanticipated adverse reactions. Adverse reactions in paediatric patients six years of age and older are expected to be similar to those seen in adults.

Read Noden Pharma press release