Merck said Monday that it's readying two FDA submissions for drugs that could bolster its cardiovascular portfolio, the company's third-largest sales division.
The first will be for anti-clotting medication Vorapaxar. The submission is a bit of a retread – the company abandoned clinical trials just two years ago
among patients with a history of stroke and acute coronary syndrome. This time Merck's approach is as a preventive measure among patients with a history of heart attack, but no history of stroke. The company said in a statement that it expects to file for this indication in the US and EU next year.
The second application is for cholesterol-lowering drug Tredaptive/MK-524-A, and is also on target for 2013 in the US and EU, the firm said. The extended-release niacin/laropiprant straddles a touchy category—an FDA study from 2011 found that niacin didn't do much in the battle to lower CV mortality. Merck shelved its niacin/simvastatin combination known as MK-0524B earlier this month
Approvals of the drugs would expand a segment of Merck's portfolio responsible for $2.4 billion in sales last year, good enough for third among the contributors to its sales tallies, behind respiratory's $5.5 billion in sales and the diabetes division's $3.3 billion in revenues.