Parker Waichman LLP

Novartis’ Tekturna Under Review After Clinical Trial Halted

Novartis’ high blood pressure drug, Tekturna, is under review after a clinical trial was suddenly halted over unwanted side effects and reduced benefits. Tekturna is in a class of drugs known as direct rennin inhibitors, is known generically as aliskiren, which is sold in the United Kingdom, and elsewhere, under the brand name Rasilez. The […]

Novartis’ high blood pressure drug, Tekturna, is under review after a clinical trial was suddenly halted over unwanted side effects and reduced benefits. Tekturna is in a class of drugs known as direct rennin inhibitors, is known generically as aliskiren, which is sold in the United Kingdom, and elsewhere, under the brand name Rasilez.

The halted study is a major blow for drug maker, Novartis, which launched Tekturna in 2007 for the treatment of high blood pressure and conducted a number of trials to determine if Tekturna could protect vital organs when taken for longer time frames, said The Wall Street Journal.

The trial that was ceased involved 8,606 Type 2 diabetes patients determined to be at increased risk for heart or kidney failure and who were taking Rasilez prescribed in addition to receiving “standard heart treatment,” said The Journal. The committee overseeing the halted study discovered greater-than-expected, unwanted adverse events once Rasilez was added to traditional treatments. Novartis ceased marketing all of its Rasilez-based products that are used in collaboration with some blood-pressure lowering drugs, noted The Journal.

The halted study revealed increased rates of nonfatal stroke, renal complications, and other problems and also indicated that the drug failed to prove more efficacious versus placebo treatment, said The Journal. Trial participants either took aliskiren or a placebo, as well as whatever blood pressure medication they had been prescribed (either an ACE inhibitor or an angiotensin receptor blocker). The study was one of a number of large, costly trials Novartis funded in an attempt to broaden Tekturna and Rasilez use and, according to Novartis, sales “are likely to be negatively impacted by the study results going forward.” Eric Althoff, a Novartis spokesman also said that the drug maker will review other, ongoing trial data, wrote The Journal, which noted that Novartis shares fell following the news.

Europe’s key drug regulator, the European Medicines Agency (EMA) announced that it was initiating a review of aliskiren’s benefits and risks and has advised doctors to stop prescribing the medication to diabetic patients also taking older generation hypertension medications (ACE inhibitors, angiotensin receptor blockers), said The Journal. Novartis said it will stop marketing aliskiren for use with ACE-inhibitors and angiotensin receptor blockers until regulators determine if the aliskiren’s marketing license needs to be amended.

We previously wrote about a study published in the American Journal of Hypertension in 2007 that called into question aliskiren’s efficacy. The study, conducted at Weill Medical College of Cornell University in New York that involved “A review of six clinical trials of aliskiren involving 5,000 patients with mild to moderate hypertension indicated that this first of a new class of orally active antihypertensive drugs is no more effective than angiotensin-converting enzyme inhibitors (CEIs), angiotensin receptor blockers (ARBs), or diuretics for lowering blood pressure,” the authors wrote.

Aliskiren is intended to reduce the body’s production of the enzyme renin, which has been shown to increase blood pressure. “Although aliskiren suppresses plasma renin activity, it causes much greater reactive rises in plasma renin concentration than does any other antihypertensive class tested,” therefore, the “consequences of its greater reactive increases in plasma renin concentration appear to offset its net ability to lower blood pressure, especially with higher doses.” In other words, the possibility exists that aliskiren actually leads to increases in blood pressure in patients with “highly reactive renin levels,” the authors added.

What Our Clients Say About Us
We have worked with thousands of clients and we appreciate them and their positive reviews. Here are just a few recent client reviews...
5 Star Reviews 150
I wanted to give huuuuugeee props to my Medical Coordinator, Joanne. She is professional, sweet, dedicated and committed to listening, comforting, and guiding me through this journey.
SooSweet NY
6 months ago
5 Star Reviews 150
I would like to thank Ms. Benita Rollis for all her help. She did a wonderful job helping me.
Tujuana Sanon
a year ago
5 Star Reviews 150
Just wanted to say thank you Parker Waichman it has been a long fight through this event also would like to thank Ms Stacy for hanging in there in keeping me updated. She did an outstanding job with a lot of care Great team work
miguel ortiz
9 months ago

Why Choose Us to Help You?

We Take Care of Everything
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
No Recovery = No Legal Fees
We work on a contingency-fee basis, meaning that we only get paid from a portion of your settlement or jury award. If you don't get compensation, you owe us nothing.
Decades of Experience
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
Respected by Our Peers
Judges, insurance adjusters, and fellow attorneys all speak highly of our skills, and we've earned numerous accolades, including a flawless rating from AVVO.
We Have Many Locations To Serve You
We have the experience and the skilled litigators to win your case. Contact us and speak with a real attorney who can help you.
Long Island – Nassau
Parker Waichman LLP
6 Harbor Park Drive
Port Washington, NY 11050
Long Island – Suffolk
Parker Waichman LLP
201 Old Country Road – Suite 145
Melville, NY 11747
New York
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038
Queens
Parker Waichman LLP
118-35 Queens Boulevard, Suite 400
Forest Hills, NY 11375
Brooklyn
Parker Waichman LLP
300 Cadman Plaza West
One Pierrepont Plaza, 12th Floor
Brooklyn, NY 11201
New Jersey
Parker Waichman LLP
80 Main Street, Suite 265
West Orange, NJ 07052
Florida
Parker Waichman LLP
27299 Riverview Center Boulevard
Suite 108
Bonita Springs, FL 34134
Nationwide Service
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038