GSK reports positive CHMP opinion for Arixtra

GlaxoSmithKline has announced that Arixtra (fondaparinux sodium) has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) as a treatment for patients with acute coronary syndromes, including two specific forms of heart attack and unstable angina.

Fondaparinux is the first compound in a new class of drugs known as antithrombotics that operate through the selective inhibiting of Factor Xa – a protein vital for the production of thrombin which is used by the body to enable blood clotting.

This positive opinion from the committee follows the review of two phase III clinical trials involving over 32,000 patients evaluating the efficacy and safety of fondaparinux.

Dr Lawson Macartney, senior vice-president of the cardiovascular and metabolic medicine development centre at GSK commented that the firm was “delighted” by the granting of a positive opinion for the compound by the CHMP.

“Fondaparinux has the potential to help [acute coronary syndrome] patients manage their condition and lead potentially longer lives,” he said.

In February 2006, GSK reported the results of the Atemis trial of Arixtra, with the company reporting that the treatment reduced the risk of venous thromboembolism by 46.7 per cent in the selected patient group.

The compound was also found to be well-tolerated in these patients and help the firm better classify the use of antithrombotics in these individuals.