Wednesday, December 13, 2017

Noden Pharma Announces FDA Approval of Tekturna (aliskiren) Oral Pellets for the Treatment of Hypertension in Adults and Children 6 Years of Age and Older

In continuation of my update on Tekturna (aliskiren)


Noden Pharma DAC, a global specialty pharmaceutical company that is focused on acquiring prescription medicines across a broad range of therapeutic areas, announced today the approval by the U.S. Food and Drug Administration of Tekturna (aliskiren) Oral Pellets for the treatment of hypertension in adults and children six years of age and older. The new formulation and pediatric indication were approved through the FDA priority review process. Noden Pharma DAC.
"This expanded indication for Tekturna provides an additional option for pediatric hypertensive patients," said Alan Markey, acting CEO of Noden Pharma DAC. "In addition, it provides an alternative dosing option for adults with hypertension."
According to hypertension guidelines published by the American Academy of Pediatrics (AAP) the prevalence of clinical hypertension in children and adolescents is ~3.5%. The prevalence of persistently elevated blood pressure is ~2.2% to 3.5%, with higher rates among children and adolescents who are overweight and those with obesity.1‍
The efficacy and safety of Tekturna® for pediatric use was evaluated in an 8-week randomized, 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 pediatric patients six years of age and older are expected to be similar to those seen in adults.
Tekturna® Oral Pellets may be taken by carefully opening the dispensing capsule and emptying the contents into a spoon then into the mouth, and then swallowing right away with water or milk (dairy or soy-based) without chewing or crushing. Alternatively, the contents can be taken orally immediately after mixing with specified dosing vehicles.
John McLaughlin, CEO of PDL BioPharma, said, "Our investment in Noden has provided us with a platform upon which to build a specialty pharmaceutical company, and we are pleased to see the team at Noden execute this important expansion of the label for Tekturna®."
Noden plans to make Tekturna® Oral Pellets available in 2018.

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