Chain Drug Review - Novartis’ Diovan O.K.’d for a new use
EAST HANOVER, N.J. — The Food and Drug Administration has approved Diovan as a treatment for reducing cardiovascular deaths in patients who are at high risk after suffering a heart attack.
The regulatory agency granted Novartis Pharmaceuticals Corp. the expanded heart failure labeling for the product, which the company says has been the world’s most prescribed ARB (angiotensin receptor blocker).
“Millions of patients already rely on Diovan to help them to maintain healthier blood pressure goals,” notes Alex Gorsky, chief operating officer. “Now, based on results from one of the largest mega-trial programs in the ARB class, Diovan has demonstrated additional benefits that can address the needs of an even broader spectrum of cardiovascular patients.
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“We remain committed to developing the full clinical potential of this agent.”
Each year an estimated 1.2 million Americans suffer a heart attack, which places them at expanded risk of repeat attacks or death. Patients who have experienced a heart attack may also progress to heart failure, a progressive condition in which the heart’s muscle weakens.
“Every day more than 3,000 patients suffer a heart attack in the United States,” points out Marc Pfeffer, professor of medicine at Harvard Medical School. “While we’ve made significant advances in recent years, death following a heart attack remains unacceptably high.”
The FDA’s approval of Diovan to reduce cardiovascular death in high-risk heart attack survivors is based on a landmark trial involving more than 14,000 patients in 24 countries.
“We are proud it has resulted in the approval of a new treatment to help improve the survival of patients at high risk following a heart attack,” adds Pfeffer, who also chaired the study that led to the FDA’s most recent approval.
Other recently completed Diovan trials involve patients with high blood pressure, while researchers continue to examine whether long-term treatment with the drug (which is also known as valsartan) delays or prevents the progression to type 2 diabetes.
For the treatment of heart failure, Diovan is available in 40-, 80- and 160-mg tablets (dosed twice daily). Diovan is also indicated for the first-line treatment of hypertension and can be administered once a day using a dosage range of 80 mg to 320 mg.
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