New drugs by Amgen Inc., Sanofi and Regeneron Pharmaceuticals
Inc. for treating heart disease, the world’s No. 1 killer, are showing signs
that they can reduce cardiovascular complications as they lower cholesterol
levels.
Repatha, made by Amgen, and Praluent, under
development by Sanofi and Regeneron, both cut cholesterol levels by more than
60 percent in studies published Sunday in the New England Journal of Medicine.
The trials also showed patients getting the injected drugs were half as likely
to die or suffer a major cardiac complication, such as a heart attack, stroke
or chest pain, after just a year to 18 months of treatment.
While the findings aren’t definitive, the
positive results will make it easier for regulators to approve the drugs based
on their cholesterol-lowering ability alone, said Steve Nissen, chief of
cardiology at the Cleveland Clinic in Ohio, who wasn’t involved in the
research. The results will also pressure insurance companies to pay for the
treatments, which analysts expect to generate more than $2 billion a year in
sales at their peak.
“It helps the companies developing these drugs
to reassure the Food and Drug Administration that early approval, based on
cholesterol-lowering benefits, is not a risky proposition,” Nissen said.
Price Competition
Neither study was designed to prove
conclusively how the drugs affect heart disease risk, Nissen said. Definitive
studies, under way for both drugs and expected to conclude in the next few
years, may not yield as dramatic a benefit, he said.
And since the two treatments are similar,
insurers will be able to put pressure on the drugmakers to compete on price.
Express Scripts Holding Co., the nation’s largest manager of prescription drug
benefits, has already described this set of cholesterol drugs as the next big
opportunity to control costs. The drugmakers haven’t said what they’ll charge
for the treatments.
The medications are the first of a new class
called PCSK9 inhibitors that can lower cholesterol levels when treatment with
statins such as Pfizer Inc.’s Lipitor aren’t enough to get patients into a
healthy range. Analysts expect the drug by Regeneron and Sanofi to reach the
market first this year, with an FDA decision by July, followed by Amgen’s
treatment in August. Pfizer also has a drug in early stages of development.
Real Impact
The Praluent study, funded by Sanofi and
Regeneron, found the drug slashed bad cholesterol, or LDL, by 62 percent and
lowered heart risks, including stroke and death from cardiovascular disease, by
48 percent. The patients were already on the maximum tolerated dose of statins
and started the trial with LDL cholesterol of 70 milligrams per deciliter or
more.
While Praluent is delivered as an injection,
which makes it less convenient than oral pills like Lipitor, Sanofi and Regeneron
“have been pleasantly surprised by how well patients have stayed in the trials
and the feedback we’ve gotten with regards to acceptance of therapy,” said Bill
Sasiela, Regeneron’s vice president of program direction for cardiovascular and
metabolic diseases. Patients can use the injections at home.
The Repatha study, funded by Amgen and
presented at the American College of Cardiology meeting in San Diego, found
just under 1 percent of patients on the medication for a year experienced a
heart complication, compared with 2.18 percent on standard treatment. Both
doctors and patients knew who was getting the medicine, which can influence the
results. The trial enrolled 4,465 patients with a median LDL of 120 milligrams
per deciliter. Under 100 milligrams is considered good for an adult.
Real Impact
“With what’s out there right now, there’s no
way to control LDL” for patients who can’t tolerate or get enough benefit from
statins, said Scott Wasserman, vice president of global development for
cardiovascular drugs at Amgen. With Repatha, doctors “have an opportunity to
really make an impact for those patients.”
While Sunday’s study only has data for one
year, it bodes well for the outcome of a multiyear, 27,500-person trial Amgen
is running that will definitively show Repatha’s effect compared with standard
care, Wasserman said. Sanofi and Regeneron are also doing a multiyear trial of
18,000 patients. Both trials are expected to yield results by the end of 2017.
Fewer Complications
Sixty patients in the Repatha study
experienced complications, including death, heart attack, chest pain, stroke, a
procedure to open a clogged artery and heart failure, said lead investigator
Marc Sabatine, from Brigham and Women’s Hospital in Boston. The events were 53
percent less likely to occur in those getting Repatha, originally developed
under the name evolocumab, and the reduced risk was similar in every area, he
said.
Neurocognitive complications, such as mild
confusion or forgetfulness, were more common with the Amgen drug, though they
occurred in fewer than 1 percent of patients, Sabatine said. Other
complications included muscle pain and eye problems.
About one-quarter of the people receiving
Repatha had their bad cholesterol fall to 25 milligrams or less, Sabatine said.
“You are starting to see levels found in
hunter-gatherer populations, where there is virtually no cardiovascular
disease,” he said. “We are getting down to LDL cholesterol levels we have only
dreamed of.”
“The absolute reduction is among the largest
ever seen with pharmacologic therapy and the lowest level achieved in any
trials.”
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