|Amgen R&D chief Sean Harper|
Amgen now has a deadline in place for an FDA decision on its cholesterol-lowering drug evolocumab. The Big Biotech put out the word Monday morning that the FDA has accepted its BLA application on the PCSK9 drug for review, giving regulators until August 27, 2015 to issue their decision on marketing the therapy.
To get to this point, Amgen has produced data from a battery of late-stage studies which underscored the treatment's ability to chop down levels of "bad" LDL cholesterol. All told there were 4,500 patients in 10 Phase III studies.
Amgen's shares ($AMGN) jumped a bit more than 1% Monday morning as investors make their bets on the biotech's shot at success.
Amgen, though, has been racing against Sanofi and Regeneron, partners on a rival PCSK9 treatment that suddenly leapfrogged ahead when they paid $67.5 million for an FDA voucher that slashes alirocumab's review time down from 10 months to 6 months. Amgen replied by filing a patent-infringement suit against the competition a few weeks ago.
"There is still a large unmet need among patients with high cardiovascular risk and elevated cholesterol who are unable to reach optimal LDL cholesterol levels with current therapies," said Amgen R&D chief Sean E. Harper in a statement. "Evolocumab has the potential to provide significant additional benefit when added to existing LDL cholesterol-lowering medications for patients with high cholesterol."
- here's the release