Tekturna Label Changes, Valturna Market Withdrawal Announced by Novartis

Novartis announced yesterday that the label for the blood pressure drug Tekturna (aliskiren) will be updated with new warnings regarding its use in people with diabetes and kidney problems. Novartis also announced it will no longer market Valturna, a single-pill combination of aliskiren and the ARB valsartan.

According to a statement from Novartis, the company is taking these actions at the request of the U.S. Food &Drug Administration (FDA), which has completed a preliminary review of its halted ALTITUDE study. The modified Tekturna labels will warn against:

• The combined use of aliskiren-based products with ACE Inhibitors and angiotensin receptor blockers (ARBs) in patients with diabetes.
• A warning against the use of aliskiren-based products in patients with moderate renal (kidney) impairment (eGFR < 60 ml/min) who are also taking an ACE inhibitor or an ARB.

In addition to Tekturna, the new warnings will be added to:

• Tekturna HCT (aliskiren and hydrochlorothiazide)
• Tekamlo (aliskiren and amlodipine)
• Amturnide (aliskiren, amlodipine and hydrochlorothiazide)

Novartis said it will continue to make Valturna available in the U.S. until July 20, 2012. Patients taking Valturna are being advised to seek guidance from their doctor prior to that date to determine appropriate alternate therapy. Novartis said it will communicate to U.S. physicians informing them of the actions it is taking in regards to Tekturna and Valturna.

Tekturna Background

Approved in 2007, Tekturna is indicated for the treatment hypertension (high blood pressure) either as monotherapy or in combination with another medication. Possible Tekturna side effects include:

• Non-fatal strokes
• Heart attacks
• Acute kidney failure and other kidney complication
• Hyperkalemia, a condition caused by abnormally high levels of potassium in the blood
• Hypotension (abnormally low blood pressure)
• Syncope (loss of consciousness)

Aliskiren is also available in combination products, including:

• Amturnide (containing Amlodipine, Hydrochlorothiazide, and Aliskiren)
• Tekamlo 150/10 (containing Amlodipine and Aliskiren)
• Tekamlo 150/5 (containing Amlodipine and Aliskiren)
• Tekamlo 300/10 (containing Amlodipine and Aliskiren)
• Tekamlo 300/5 (containing Amlodipine and Aliskiren)
• Tekturna HCT 150/12.5 (containing Hydrochlorothiazide and Aliskiren)
• Tekturna HCT 150/25 (containing Hydrochlorothiazide and Aliskiren)
• Tekturna HCT 300/12.5 (containing Hydrochlorothiazide and Aliskiren)
• Tekturna HCT 300/25 (containing Hydrochlorothiazide and Aliskiren)
• Valturna (containing Aliskiren and valsartan)

ALTITUDE Study

The ALTITUDE clinical trial was designed to evaluate the effect of aliskiren on the likelihood of cardiovascular and kidney events in high-risk diabetic patients. The more than 8,600 type-2 diabetes patients enrolled in ALTITUDE were treated with either aliskiren or a placebo, as well as whatever blood pressure medication they had been prescribed – either an ACE inhibitor or an ARB. The study was one of a number of large, costly trials Novartis funded in an attempt to broaden the use of Tekturna.

This past December, Novartis announced ALTITUDE had been halted after an independent review committee noted higher adverse events in patients receiving aliskiren in addition to standard of care in the trial. There was also an increased incidence after 18-24 months of serious side effects in the high risk population, including non-fatal stroke, kidney complications, hyperkalemia, and hypotension. As a precautionary measure, Novartis stopped promotion of Tekturna and combination products containing aliskiren in combination with an ACE inhibitor or ARB in December.