PCSK9 drugs

Latest Headlines

Latest Headlines

PCSK9 drugmakers go Big Data to ID more eligible patients

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.

Discounts make room for both Sanofi, Amgen's PCSK9 meds on Express Scripts' top formulary

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.

AZ's high-powered Crestor could gain from payer limits on PCSK9 meds

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.

Alnylam, Medicines Co. say next-gen PCSK9 drug has blockbuster potential

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.

UPDATED: Amgen gets a big win with FDA OK for PCSK9 cholesterol drug Repatha

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 line up for second place in EU cardio race

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's PCSK9 spoiler clears another FDA roadblock as it heads to Phase III

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.

Ready to prescribe PCSK9 meds? Doctors say yes, yes, yes

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's cardio contender clears FDA panel, but it's hardly a clean sweep

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.

FDA says Sanofi and Regeneron's cardio contender looks approvable. But for whom?

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.