When the FDA approved the first in a new generation of PCSK9 cholesterol fighters, the agency limited that approval to patients with familial hypercholesterolemia (FH), a hereditary form of ultrahigh cholesterol, and those who still have high cholesterol levels after aggressive doses of statins. Problem is, many people don't know they have FH. And that, reports CardioBrief, is where a concerted search-and-training effort comes in.
At Express Scripts, both Sanofi and Regeneron's Praluent and Amgen's Repatha scored a spot on the preferred formulary, which gives both PCSK9 products a chance to snare the pharmacy benefits manager's patients.
Payers are already looking for ways to forestall spending on new, high-priced PCSK9 drugs--and that could mean good things for AstraZeneca's high-powered statin, Crestor. But it's the soon-to-hit Crestor generics that could prove an even bigger thorn in the sides of PCSK9 drugmakers.
Now that Amgen and the Regeneron/Sanofi team have scored pioneering approvals of two leading PCSK9 therapies, the race is already on to top the leaders with a new wave of even better drugs that can slash levels of bad cholesterol more efficiently. And Alnylam, alongside its partners at The Medicines Company, has staked out a claim to an RNAi treatment that could beat them all--some 5 years down the road.
Amgen scored the big win for its PCSK9 drug Repatha (evolocumab). The FDA announced Thursday afternoon that it has given Amgen a green light on marketing the PCSK9 cholesterol drug, opening the door to what will likely prove a blockbuster market.
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.