The Committee for Medicinal Products for Human Use has issued a positive opinion on the marketing authorization application for AstraZeneca's Brilique--also known as Brilinta--to prevent atherothrombotic events in adult patients with acute coronary syndromes. The positive opinion will now be referred for a final determination by the European Commission, which typically makes its decision within a few months of the CHMP issuing its opinion.
"Despite advancements in the treatment of ACS, post-ACS death rates remain high," says Anders Ekblom, executive VP, global medicines development, AstraZeneca. "If approved by the European Commission, BRILIQUE will provide an important treatment option for physicians treating patients with ACS."
AstraZeneca is relying on revenues from Brilinta--whose sales may reach $1.95 billion by 2014, according to some analysts--to offset expiring patents on some of its best-selling medicines, Reuters notes. Indeed, AstraZeneca faces the expiration of patents in the next four years on the heartburn drug Nexium and the antipsychotic Seroquel, which generated a combined $9.83 billion in revenue last year, Bloomberg points out. Brilinta/Brilique is expected to compete against Sanofi-Aventis and Bristol-Myers Squibb's mega-blockbuster drug Plavix, which had sales last year of more than $9.5 billion. The drug is off patent in parts of Europe and will lose U.S. patent protection in 2012.
Earlier this month, the FDA extended the time to complete its review of the application for Brilinta. The PDUFA date has been moved to December 16.
ALSO: The CHMP has been busy. In addition to issuing opinions on Brilique and a Merck KGaA drug, it also recommended approval of Novartis' Tobi Podhaler (tobramycin inhalation powder), a fast and convenient inhaled therapy for use by patients with cystic fibrosis. Novartis release