FDA Approval: Brilique
LONDON, Dec 6 (Reuters) – AstraZeneca’s new heart medicine Brilique — or Brilinta — won final clearance from EU regulators on Monday, putting it on track to compete with Plavix, the world’s second biggest-selling drug, next year.
AstraZeneca is relying on revenues from the new product to offset expiring patents on some of its best-selling medicines, such as heartburn treatment Nexium and Seroquel for schizophrenia.
The approval by the European Commission had been expected following a positive recommendation from experts at the European Medicines Agency in September.
AstraZeneca said that of the European markets that would start selling Brilique in 2011, the majority of launches would occur in the second half of the year due to pricing and reimbursement negotiations.
The drug is recommended for preventing dangerous blood clots in patients with serious chest pain or previous heart attacks.
It is a competitor for Sanofi-Aventis and Bristol-Myers Squibb’s top-seller Plavix, which had sales last year of more than $9.5 billion, and AstraZeneca will face a tough competitive marketplace, since Plavix is off patent in parts of Europe and loses U.S. patent protection in 2012.
In the United States, where the medicine will be sold as Brilinta, the Food and Drug Administration is due to decide on whether to approve it by Dec. 16. It was endorsed by a U.S. advisory panel in July, despite a perplexing lack of benefit seen among a North American sub-group of patients in a clinical trial that found it was superior to Plavix overall. (Reporting by Ben Hirschler, editing by Kate Kelland)