Sanofi and Regeneron may be on pace to win the first U.S. approval for a new type of cholesterol treatment, but the pair trails rival Amgen in Europe in a race to make good on blockbuster sales predictions.
Esperion, at work on a cholesterol-lowering pill it hopes can disrupt some high-profile new injections, convinced the FDA to remove a partial clinical hold on the highest dose of its drug.
After last week's expert panel meetings, the FDA may put some label limits on PCSK9 cholesterol drugs. But if word from doctor surveys is any indication, those limits won't put a huge damper on sales.
Amgen won the support of FDA advisers with its potentially game-changing new cardiovascular treatment, but the agency panel cautioned against widespread use of the injection until its long-term safety is better understood.
A potential blockbuster from Sanofi and Regeneron has proven its ability to slash rates of cholesterol, the FDA said, but questions remain on just how widely the treatment should be used.
Amgen is likely to come in second in the race to launch new cholesterol treatments in the U.S., but the Big Biotech is leading the charge in Europe, securing a crucial regulatory recommendation that clears the way for approval.
Amid all the fervor over cholesterol-fighting PCSK9 antibodies, Esperion Therapeutics is touting more positive results for a pill it hopes will play spoiler to those would-be-blockbuster injections.
A new generation of cardiovascular drugs has proved itself capable of lowering bad cholesterol across dozens of Phase III trials, but many physicians are holding out to see whether doing so can meaningfully improve patients' lives. In an early peek at some long-term data, one such injected therapy from Amgen halved the risk of major cardiovascular problems after one year of treatment, bolstering the case for the whole class of drugs.
Amgen just lost a key regulatory race. Armed with a handy FDA shortcut voucher, Regeneron and its Big Pharma partner Sanofi announced today that the agency has accepted their application for the powerful new PCSK9 cholesterol drug alirocumab and set a priority deadline of July 24 for their marketing decision. If they get a quick green light, as many analysts expect, their decision to buy the priority review voucher will be rewarded with first-mover advantage with U.S. payers as Amgen sits out an FDA game clock that ends August 27.
SAN FRANCISCO-- Keeping up the rear in a three-way race to commercialize the first of a new class of anticholesterol antibodies, Pfizer is at work on a pill that attacks the same target, planning to build a franchise in what is expected to be a blockbuster new therapeutic area.