GlaxoSmithKline received yet more positive news yesterday after the European Medicines Agency’s Committee for Medicinal Products for Human Use recommended approval of a second product, this time Arixtra for acute coronary syndromes, in a matter of days.
ACS conditions, which collectively affect around 3 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.
The CHMP’s 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.
But across the Atlantic, the group’s quest for approval in ACS suffered a setback after US regulators issued an approvable letter for the drug in February, following a six-month priority review. 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.
Arixtra (fondaparinux) 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.