Federal regulators approved another new cholesterol drug that could help patients with extremely high cholesterol, but will it be too pricey like its predecessor?
The Food and Drug Administration approved on late Thursday Repatha, an injection for some patients who are unable to get their cholesterol under control.
The drug is the second in a new class of treatments called PCSK9 inhibitors. The gene PCSK9 reduces the number of receptors on the liver that remove low-density lipoprotein cholesterol, which is commonly known as the bad cholesterol that can clog blood vessels.
By blocking PCSK9, more receptors can get rid of bad cholesterol from the blood and lower cholesterol levels, the FDA said.
Repatha, which will be manufactured by Amgen, is approved for use in patients alongside a good diet and statin therapy.
It is the second PCSK9 inhibitor to be approved, after Sanofi’s Praulent in late July. Insurers criticized Sanofi for its planned cost of the drug, which is nearly $14,000 for a year of treatments.
The Amgen drug appears to be about the same cost with $14,100. Amgen said the cost could be mitigated through discounts or rebates. Amgen said it hopes to have Repatha on the market by next week.
While that number is less than some pricey specialty drugs, PCSK9 inhibitors have to be taken for long periods of time through a series of injections, according to a blog post in the journal Health Affairs.
“As this is chronic therapy, PCSK9 sales could be expected to persist and grow over time, and will likely be the highest selling class of medications in history,” according to Health Affairs.
