A new cholesterol-lowering medication manufactured by Esperion Therapeutics was approved by the Food and Drug Administration on Friday, a decision that will allow the company to test whether price is the biggest barrier to new heart medications on the market.
Heart drugs have had a tough go of it in recent years. Repatha and Praluent, expected to be multibillion sellers, instead saw sales stagnate. Their makers took the unusual step of cutting the drugs’ prices by 60%. Entresto, a Novartis heart failure drug, had a slow start before sales took off. But now there is broadened interest. Amarin expects sales of its fish-oil-derived pill, Vascepa, of upwards of $650 million this year. And, early this year, Novartis spent $9.7 billion to buy The Medicines Company, which is developing a long-acting cholesterol lowering medicine.
it sounds like no data when added to a statin, and of course they don’t have CV events outcomes data (no one does at approval), so this is just a treatment for people who can’t tolerate a statin. And they’ll probably need to fail Zetia (ezetimibe) too. this is not competing with the injections – it competes with generic statins and ezetimibe.
upon additional reading, this does have add-on to statin data. Based on this, I rescind my previous comment – there is clearly significant potential. However even a 1% incidence of ruptured tendon is going to keep this drug in reserve. That is not a minor safety risk.
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