Blockbuster Friday: Sanofi/Regeneron wins first US approval of PCSK9 cholesterol med
- Call it Blockbuster Friday: The FDA has approved Sanofi/Regeneron's expected hit PCSK9 inhibitor cholesterol drug Praluent, making it the first drug of its class to win regulatory approval in the U.S.
- But that's not all. The agency issued several major product approvals on Friday, including AbbVie's Technivie, which targets the rarest genotype of hepatitis C (genotype 4); Bristol-Myers Squibb's Daklinza in combination therapy with Gilead's Sovaldi for HCV genotype 3; and Novartis' Odomzo for basal cell carcinoma (skin cancer).
- The Praluent approval is for adults with heterozygous familial hypercholesterolemia (HeFH). It is also indicated for high-risk CVD patients (such as heart attack or stroke patients) who don't achieve enough cholesterol reduction benefit from statin therapy alone. UPDATE: Sanofi/Regeneron also announced that they would be pricing Praluent at $40 per day, or $1,120 every 28 days. That works out to $14,600 per year (assuming 365 days per year of treatment) and is certain to give payers some heartburn.
Earlier this week, Amgen won some bragging rights as it became the first company in the world to have a PCSK9 drug (Repatha) approved after the European Commission gave it the green light. But Sanofi/Regeneron have arguably pulled off a more significant victory by becoming the first in this widely expected blockbuster class to gain entry into the US market.
"The FDA strongly supports continued work to provide new and innovative options for the treatment and prevention of cardiovascular disease," said Dr. John Jenkins, director of the Office of New Drugs at the CDER, in a statement.
Now that it's cleared its most significant regulatory hurdle, Praluent's next major battle will be with payers and providers. One pharmacy benefits manager, Prime Therapeutics, estimates that PCSK9 meds could cost a whopping $23.3 billion per year, with estimated drug costs per patient falling somewhere between $7,000 to $12,000. As it turns out, that was actually drastically underestimating the cost, as Praluent will cost $14,600 per year at $40 per day.
This may be an attractive pricing option for Sanofi/Regeneron and Amgen given the relatively limited reach of these cholesterol drugs in the context of the much wider CVD market. Much of this cost would be borne by the Medicare Part D prescription drug program.
The FDA's other drug approvals today shouldn't be shrugged off, either. But Praluent is sure to be the talk of the town for now. In trials, these LDL-C lowering drugs have been shown to cut bad cholesterol levels by as much as 60% and led to reductions in serious CVD events that lead to hospitalizations.
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