SEPTEMBER 24,
2018
The
biopharma company Amarin is making some heart-medicine history Monday with its
proprietary, prescription formulation of fish oil, called Vascepa.
In a
stunning clinical trial result that upends years of skepticism about the
long-term heart benefit of products containing omega-3 fatty acids, Amarin’s
Vascepa significantly reduced the risk of deaths, heart attacks, strokes, and
other serious cardiovascular events compared to a placebo.
Amarin
designed its cardiovascular outcomes study, known as REDUCE-IT, hoping to show
Vascepa could meet the primary endpoint with a 15 percent risk reduction.
The
result announced Monday: a 25 percent risk reduction — highly statistically
significant.
“This is
absolutely the most significant study in the field of cardiovascular risk
reduction since the statins were introduced,” said Dr. Matthew Budoff, a
cardiologist at UCLA and a Vascepa study investigator.
Statins became
commercial blockbusters generating billions of dollars in sales because large
clinical trials proved a positive link between cholesterol lowering and the
prevention of fatal heart attacks and strokes. The newer class of injectable
cholesterol-lowering medicines known as PCSK9 inhibitors from Amgen, Regeneron
Pharma, and Sanofi reduce cardiovascular risk by 15 percent.
With a
greater 25 percent reduction risk for patients, Vascepa could be the next
cardiovascular blockbuster therapy, potentially prescribed to millions of
Americans.
Amarin
shares closed Friday at $2.99. As dawn broke Monday, Amarin’s stock price
surged to $10, a 200 percent-plus move higher in the pre-market trading
session.
Vascepa
was approved by the Food and Drug Administration in 2012 to treat people with
high levels of triglycerides, a type of fat found in blood. But the product’s
commercial output has been modest to date — sales last year totaled $181
million — because there was no scientific proof linking triglyceride lowering
to improved cardiovascular outcomes.
All
previous outcomes studies investigating different formulations of
omega-3-containing products have been unsuccessful, leading to heavy skepticism
in the cardiology community about the medicinal value of these supplements. As
recently as August, a 15,000-patient study of a different prescription-grade
fish oil called Lovaza failed to detect any improvement in heart
benefits.
“I
thought the Vascepa study would be negative, colored by all the prior failed
studies so I’m surprised. I’m willing to eat my shoe on this one. This could be
really beneficial to people,” said Dr. Ethan Weiss, a cardiologist at the
University of California, San Francisco Medical Center. Weiss was not involved
in the Amarin study.
“I need
to see the [detailed] data, but if these are the results, then this may be a
game changer,” said Dr. Martha Gulati, chief of cardiology at the University of
Arizona College of Medicine. Gulati was not involved in the Amarin study.
Amarin
used a press release Monday morning to disclose the top-line results from the
Vascepa REDUCE-IT study. More detailed data are being presented at the American
Heart Association annual meeting on Nov. 10.
Amarin
has long insisted that the special characteristics of Vascepa would prove
superior to other fish oil formulations. Vascepa contains only highly purified
EPA, the most beneficial omega-3 fatty acid. Other fish oil pills, including
Lovaza, contain a mix of EPA and DHA, the latter of which is known to raise
levels of bad cholesterol. Vascepa is given at a higher 4-gram daily dose
compared to competitors.
The company
designed the REDUCE-IT study to maximize Vascepa’s benefit. The 8,179 patients
entered the study with cholesterol levels that were controlled by statin
therapy but they also had other heart-related ailments, including persistently
high triglyceride levels or diabetes, that placed them at greater risk.
The
patients were randomized to treatment with Vascepa or a placebo pill and
followed for a median of nearly five years. The results:
Vascepa
demonstrated an approximately 25 percent relative risk reduction in the primary
endpoint, which measured first occurrence of cardiovascular death, non-fatal
heart attack, non-fatal stroke, coronary revascularization, or unstable angina
requiring hospitalization, Amarin said.
On
safety, Vascepa was well-tolerated with a side effect profile consistent with
the drug’s currently approval label, the company said.
“We are
delighted with these top-line study results,” Amarin CEO John Thero said in a
statement. “Given Vascepa is affordably priced, orally administered and has a favorable
safety profile, REDUCE-IT results could lead to a new paradigm in treatment to
further reduce the significant cardiovascular risk that remains in millions of
patients with LDL-C controlled by statin therapy, as studied in REDUCE-IT.”
The 25
percent risk-reduction headline number is significant, but Weiss, the UCSF
cardiologist, said he’s holding off on hailing the finding as the most
significant until details from the study data are aired publicly in November.
He has questions: What factors, exactly, drove the risk reduction? How much
triglyceride lowering was observed? How narrow was the enrolled patient
population?
But if
the data hold up, Vascepa could become a very big drug. At an annual price of
around $2,400, Vascepa is already broadly covered by insurance companies. Even
if Amarin raises the drug price to reflect the REDUCE-IT results, it will still
likely be a relative bargain compared to other heart medicines. PCSK9
inhibitors cost about $14,000 annually and insurers have tried to restrict their
use.
Amarin
has already been involved in litigation against generic drug makers seeking to
bring cheaper versions of Vascepa to the market. The company’s patents on the
drug expire in 2030, although the results of the REDUCE-IT study, bolstered by
additional FDA approvals, could offer more intellectual property protections.
Amarin
also believes the cardiovascular benefit seen in REDUCE-IT is due to Vascepa’s
purity and dose and cannot be replicated by other prescription-grade or
over-the-counter fish oil products. Whether that proves to be true, or not,
will depend on the results of competing clinical trials. AstraZeneca is
conducting an outcomes study of its prescription-grade fish oil product called
Epanova, also utilizing a higher dose, like Vascepa. A readout from that study,
dubbed STRENGTH, could come next year.
“I went
into this study not convinced that Vascepa would make a difference, but these
results will definitely change my practice and the way I treat patients,” said
Dr. Norman Lepor, a cardiologist at Cedars-Sinai Medical Center in Los Angeles.
Lepor enrolled patients in the Vascepa study.
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