Life-saving licence to boost Diovan
pharmafile | December 2, 2004 | News story | |
Sales of Novartis' hypertension treatment Diovan look set to increase following the granting of a new European Union licence for its life-saving properties in post-heart attack patients.
Diovan is the first drug in the Angiotensin Receptor Blocker (ARB) class to gain a licence for post myocardial infarction (MI) in patients with evidence of left-sided heart failure, and will help it gain ground in the highly competitive cardiovascular market.
Earning $2.28 billion in the first nine months of 2004 makes it Novartis' biggest product, but it will have to overtake Pfizer's ageing calcium channel blocker Norvasc ($3.2 billion in the same period) if it is to become the world's biggest blood pressure medication.
To achieve this aim, Novartis is offering a money back guarantee to US patients, a consumer-style tactic being spearheaded by chief executive Thomas Ebeling, a former Pepsi executive.
In the UK, Diovan still lags behind Merck Sharp & Dohme's Cozaar as the number one ARB, but the new licence should help close the gap.
Diovan's new licence has also been approved in EU reference state Sweden and the company is now expecting approvals across the continent in the coming months. The company recently invested CHF 60 million in expanding production capacity for the product at its manufacturing facility in Schweizerhalle, Switzerland.
Positive results from the VALIANT (Valsartan In Acute Myocardial Infarction) trial, one of the largest long-term studies ever conducted in post-MI patients, helped secure the approval.
More than 14,500 patients tool part in the trial, which showed Diovan to be as effective as the ACE inhibitor captopril in post-MI patients. Diovan was also shown to improve patient survival rates, reduce mortality and the incidence of a number of associated cardiac conditions such as heart failure, cardiac arrest and stroke.
ACE inhibitors have demonstrated life-saving qualities but a quarter of all post-MI patients in the UK are not prescribed this treatment and one in three discontinues treatment within a year. Novartis says this is often due to adverse events, and claim Diovan's superior side-effect profile meant 30% fewer patients stopped taking the newer drug.
Earlier this year, the Novartis-sponsored VALUE (Valsartan Antihypertensive Long-term Use Evaluation Trial) study compared Diovan with Pfizer's Norvasc, unexpectedly showing Diovan to be no better than its rival in cutting heart disease and fatal heart attacks and less effective at lowering blood pressure.
Meanwhile, AstraZeneca's selective ARB Atacand (candesartan cilexetil) has received EMEA approval for the treatment of patients with heart failure and impaired left ventricle systolic function, adding to its hypertension indication.
Atacand is the first ARB to receive such a broad indication to treat chronic heart failure and it can be used either in addition to, or instead of, an ACE inhibitor. In the US the FDA is still considering whether to grant Atacand approval for a similar indication.
This would boost sales as well as Atacand's chances of taking on the market leading ARB, Novartis' Diovan, sales of which grew 46% to 2.4 billion in 2003, well ahead of Atacand's 32% growth to $750 million.
