DUBLIN, Nov. 15, 2017 /PRNewswire/ -- 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 is a wholly-owned subsidiary of PDL BioPharma,
Inc. (Nasdaq: PDLI).
"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.
For full prescribing information and patient information for
TEKTURNA, including BOXED Warning, Contraindications, and Warnings
and Precautions, please visit www.tekturna.com.
INDICATIONS and USAGE
TEKTURNA is indicated for the
treatment of hypertension in adults and children 6 years of age and
older, to lower blood pressure. Lowering blood pressure reduces the
risk of fatal and nonfatal cardiovascular events, primarily strokes
and myocardial infarctions. These benefits have been seen in
controlled trials of antihypertensive drugs from a wide variety of
pharmacologic classes. There are no controlled trials demonstrating
risk reduction with TEKTURNA. Control of high blood pressure should
be part of comprehensive cardiovascular risk management, including,
as appropriate, lipid control, diabetes management, antithrombotic
therapy, smoking cessation, exercise, and limited sodium intake.
Many patients will require more than one drug to achieve blood
pressure goals.
IMPORTANT SAFETY INFORMATION
WARNING: FETAL
TOXICITY
- When
pregnancy is detected, discontinue TEKTURNA as soon as possible.
(5.1)
- Drugs that act
directly on the renin-angiotensin system can cause injury and death
to the developing fetus. (5.1)
|
Contraindications: Do not use TEKTURNA with angiotensin
receptor blockers (ARBs) or angiotensin-converting enzyme
inhibitors (ACEIs) in patients with diabetes because of increased
risk of renal impairment, hyperkalemia, and hypotension. TEKTURNA
is contraindicated in patients with hypersensitivity to any of its
components. Tekturna is contraindicated in pediatric patients less
than 2 years of age.
Anaphylactic Reactions and Head and Neck Angioedema:
Hypersensitivity reactions such as anaphylactic reactions and
angioedema of the face, extremities, lips, tongue, glottis, and/or
larynx have been reported in patients treated with aliskiren and
have necessitated hospitalization and intubation. This may occur at
any time during treatment and has occurred in patients with and
without a history of angioedema with ACEIs or angiotensin
receptorantagonists. Discontinue TEKTURNA immediately in patients
who develop anaphylactic reactions or angioedema, and do not
readminister.
Hypotension: In patients with an activated
renin-angiotensin-aldosterone system (RAAS), such as volume- and/or
salt-depleted patients receiving high doses of diuretics,
symptomatic hypotension may occur in patients receiving RAAS
blockers. Correct these conditions before administering TEKTURNA,
or start the treatment under close medical supervision.
Impaired Renal Function: Avoid combined use of aliskiren
with ARBs or ACEIs in patients with renal impairment (creatinine
clearance less than 60 mL/min). Monitor renal function periodically
in patients receiving aliskiren, as changes in renal function,
including acute renal failure, can be caused by drugs that affect
the RAAS and by diuretics. Patients whose renal function may depend
in part on the activity of the RAAS (e.g. patients with renal
artery stenosis, severe heart failure, post-MI, or volume
depletion) or patients receiving ARBs, ACEIs, or nonsteroidal
anti-inflammatory drugs (NSAIDs), including selective
Cyclooxygenase-2 inhibitors (COX-2 inhibitors), may be at
particular risk for developing acute renal failure on aliskiren.
Consider withholding or discontinuing therapy in patients who
develop a clinically significant decrease in renal function. Safety
and effectiveness of aliskiren in patients with severe renal
impairment (creatinine clearance less than 30 mL/min) has not been
established.
Hyperkalemia: Monitor serum potassium periodically in
patients receiving aliskiren. Drugs that affect the RAAS can cause
hyperkalemia. Risk factors for the development of hyperkalemia
include renal insufficiency, diabetes, and combination use of
aliskiren with ARBs or ACEIs, NSAIDs, potassium supplements, or
potassium-sparing diuretics.
Cyclosporine, or Itraconazole: Avoid use of TEKTURNA with
cyclosporine or itraconazole.
Common AEs: Adverse events (AEs) with increased rates for
TEKTURNA compared with
placebo included diarrhea (2.3% vs 1.2%), cough (1.1% vs 0.6%),
rash (1.0% vs 0.3%), hyperkalemia (0.9% vs 0.6%), elevated uric
acid (0.4% vs 0.1%), gout (0.2% vs 0.1%), and renal stones (0.2% vs
0%).
Lactation: Breastfeeding is not recommended during
treatment with TEKTURNA.
Relationship to meals: Advise patients to establish a
routine pattern for taking TEKTURNA tablets. High-fat meals
decrease absorption substantially.
Overdosage: Limited data are available and the most
likely manifestation of overdosage would be hypotension. If
symptomatic hypotension occurs, supportive treatment should be
initiated. As aliskiren is poorly dialyzed, hemodialysis is not
adequate to treat overexposure.
About Noden Pharma
Noden Pharma DAC is a global
specialty pharmaceutical company that is focused on acquiring
prescription medicines across a broad range of therapeutic areas in
international markets. The company focuses its resources on
acquiring and optimizing established medicines. Corporate
headquarters are located in Dublin,
Ireland. For more information on Noden Pharma DAC please
visit www.nodenpharma.com.
Noden Pharma DAC is a wholly-owned subsidiary of PDL BioPharma,
Inc. (NASDAQ: PDLI). For more information on PDL BioPharma
please visit www.pdl.com.
1. Flynn JT,
Kaelber DC, Baker-Smith CM, et al. Clinical Practice Guideline for
Screening and Management of High Blood Pressure in Children and
Adolescents. Pediatrics. 2017;140(3):e20171904
|
View original
content:http://www.prnewswire.com/news-releases/noden-pharma-announces-fda-approval-of-tekturnaaliskiren-oral-pellets-for-the-treatment-of-hypertension-in-adults-and-children-6-years-of-age-and-older-300556696.html
SOURCE Noden Pharma DAC