UK drug giant GlaxoSmithKline received a boost yesterday on news that the European Medicines Agency has approved a new indication for its once-daily blood thinner Arixtra, allowing its use for the treatment of acute coronary syndromes.
The green light for Arixtra (fondaparinux) was based on a review of two large-scale, pivotal Phase III trials involving more than 32,000 patients (OASIS 5 and 6), which demonstrated the drug’s safety and efficacy in reducing the risk of death, recurrent heart attack and all-cause mortality in patients with ACS compared to treatment with heparin or a placebo.
“The mortality benefit with fondaparinux compared to enoxaparin [Sanofi-Aventis’ Lovenox] and the European authorisation of fondaparinux may allow physicians to consider a new treatment option for appropriate ACS patients,” commented Andrew Zambanini, Director of Cardiovascular and Metabolic Medicine Development Centre at the firm.
ACS conditions, which collectively affect around three million people worldwide, include chest pain (unstable angina) and two specific types of heart attacks: non-ST segment elevation myocardial infarction (NSTEMI) and ST segment elevation myocardial infarction (STEMI), and patients have an increased immediate and long-term risk of recurrent heart attack and cardiac death, the company notes.
First in class
Arixtra is the first in a class of antithrombotics that selectively inhibit Factor Xa, which plays a key role in production of the blood-clotting agent thrombin. The drug is already on the market for the prevention of venous thromboembolic events in patients undergoing abdominal surgery, major orthopaedic surgery of the lower limbs, and acutely ill medical patients who are immobilised.
The approval for ACS in Europe is certainly good news for the group, particularly as it was met with an obstacle in the USA after regulators issued the drug with an approvable letter in February. At the time, GSK gave no details as to what the letter was requesting, and limited itself to saying that will continue to work with the Food and Drug Administration to provide the additional information.