With FDA OK, Amgen’s Heart Drug Faces Rival (And Health Budgets)

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statins, before paying for the new drugs. Wilemon said her foundation is collecting data on denials of coverage for alirocumab that insurers have already begun to issue to people with FH.

People who have stubbornly high cholesterol for other reasons, such as statin intolerance, might also have trouble getting coverage. Insurers have said they will want hard evidence of intolerance before paying for a switch to costlier medicine.

Discussing the alirocumab approval last month, Regeneron officials were circumspect about the potential pool of patients that might receive their drug. Regeneron’s top commercial executive Bob Terifay said 8 to 10 million people potentially fall under the populations described by the FDA—“people who are on statins but not ‘at goal’”—in other words, they’re not at the cholesterol levels their doctors have deemed healthy.

But Terifay added that alirocumab would only be prescribed for people who have reached a maximum dose on statins yet still need to lower cholesterol. Terifay said Regeneron would have an “education program” to make sure that people taking statins are up to their maximum dose. Such a program could “limit the patient population eligible for PCSK9 inhibitors,” he said.

The link between PCSK9 drugs and better health is only indirect. In clinical trials, they’ve shown to be effective at lowering cholesterol—which is good enough for FDA approval—but it will take longer-term studies to show that they lead to fewer heart attacks, strokes, and deaths. Such studies are ongoing, run by Amgen, Sanofi/Regeneron, and Pfizer, and should produce data in 2017 and 2018.

The approval was announced after market close Thursday. Amgen shares were up $1.74, just over 1 percent, in after-hours trading. Regeneron shares were up $2.53, about half a percent, and Sanofi was up 95 cents, nearly two percent.

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