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PCSK9 drugs

Latest Headlines

Latest Headlines

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.

Amgen's PCSK9 contender lines up for first place in the blockbuster EU race

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.

Esperion's potential PCSK9 spoiler scores more positive data

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.

Amgen scores a victory for PCSK9, halving cardio risks after one year

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.