FDA approves Merck & Co's new blood thinner Zontivity

The US Food and Drug Administration yesterday approved US pharma giant Merck & Co’s (NYSE: MRK) Zontivity (vorapaxar) tablets to reduce the risk of heart attack, stroke, cardiovascular death, and need for procedures to restore the blood flow to the heart in patients with a previous heart attack or blockages in the arteries to the legs.

Zontivity is the first in a new class of drug, called a protease-activated receptor-1 (PAR-1) antagonist. It is an anti-platelet agent, designed to decrease the tendency of platelets to clump together to form a blood clot. By decreasing the formation of blood clots, Zontivity decreases the risk of heart attack and stroke, the FDA stated. The approval was largely expected as, in January, the FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 10-1 in favor of approval for vorapaxar (The Pharma Letter January 16).

Like other drugs that inhibit blood clotting, Zontivity increases the risk of bleeding, including life-threatening and fatal bleeding. Bleeding is the most commonly reported adverse reaction in people taking Zontivity. The drug’s prescribing information (label) includes a Boxed Warning to alert health care professionals about this risk.

Will join crowded, but growing anticoagulant market

Merck plans to launch Zontivity in the USA next quarter, but the drug will join a crowded field of new blood thinning drugs, including Boehringer Ingelheim's Pradaxa (dabigatran etexilate); Johnson & Johnson and Bayer Healthcare's Xarelto (rivaroxaban) and Pfizer Inc. and Bristol-Myers Squibb's Eliquis (apixaban). EvaluatePharma predicts that the market for anticoagulant drugs will soar by 11.5% annually through 2018, hitting $15.3 billion in sales. The market is currently valued at $8 billion.