Esperion (NASDAQ: ESPR) today announced that the Committee for
Medicinal Products for Human Use (CHMP) of the European Medicines
Agency (EMA) has adopted a positive opinion for the MAA for the
bempedoic acid / ezetimibe fixed dose combination tablet,
recommending approval for the treatment of hypercholesterolemia and
mixed dyslipidemia. The positive CHMP opinion was achieved with no
Oral Explanation as the Rapporteurs found there were no substantive
issues that needed to be discussed with the CHMP at the time of the
vote.
The benefits with the bempedoic acid / ezetimibe
fixed dose combination tablet are its ability to reduce levels of
LDL-C, but also non-high density lipoprotein cholesterol
(non-HDL-C), apolipoprotein B (apo B), and total cholesterol (TC)
in patients with hypercholesterolaemia or mixed dyslipidaemia when
administered alone and in combination with other lipid-modifying
medicinal products. The most common side effects are hyperuricaemia
and constipation.
The CHMP recommended granting the bempedoic acid /
ezetimibe fixed dose combination tablet marketing authorisation for
the treatment of adults with primary hypercholesterolaemia
(heterozygous familial and non-familial) or mixed dyslipidaemia, as
an adjunct to diet:
- in combination with a statin in patients unable to reach LDL-C
goals with the maximum tolerated dose of a statin in addition to
ezetimibe,
- alone in patients who are either statin-intolerant or for whom
a statin is contraindicated, and are unable to reach LDL-C goals
with ezetimibe alone, or
- in patients already being treated with the combination of
bempedoic acid and ezetimibe as separate tablets with or without
statin.
The CHMP is a scientific committee of the EMA that
reviews medical product applications on their scientific and
clinical merit. The European Commission will review the CHMP
opinion and is expected to adopt a final decision in April 2020.
The decision will be applicable to all 27 European Union member
states plus the United Kingdom, Iceland, Norway and
Liechtenstein.
The positive CHMP opinion for the bempedoic acid /
ezetimibe fixed dose combination tablet is supported by the Phase 3
Fixed Dose Combination Tablet LDL-Cholesterol Lowering program. The
bempedoic acid / ezetimibe fixed dose combination tablet positive
opinion is based on data from the pivotal Phase 3 053 Study
conducted in more than 300 patients, as well as safety data from
the bempedoic acid global pivotal Phase 3 LDL-C Lowering program
together with the established ezetimibe safety profile. The
bempedoic acid / ezetimibe fixed dose combination tablet
significantly reduced LDL-C 38 percent from baseline to
week 12 compared with placebo. Results from the pivotal Phase
3 053 Study have been published in The European Journal of
Preventative Cardiology.
Daiichi Sankyo Europe has licensed exclusive
commercialization rights to bempedoic acid and the bempedoic acid
/ezetimibe fixed dose combination tablets in the European Economic
Area and Switzerland from Esperion. Daiichi Sankyo’s European
cardiovascular commercial capabilities include more than 1,000
professionals dedicated to the commercialization of cardiovascular
medicines and includes synergies with an existing portfolio of
novel oral anticoagulant and antiplatelet products. Upon approval,
Daiichi Sankyo Europe intends to make bempedoic acid and the
bempedoic acid / ezetimibe fixed dose combination tablets available
to physicians and their patients in these geographies that need
treatment for hypercholesterolemia and mixed dyslipidemia.
Bempedoic acid and the bempedoic acid / ezetimibe
fixed dose combination tablets are being developed globally as
affordable, convenient, oral, once-daily, non-statin medicines for
the treatment of patients with elevated LDL-cholesterol (LDL-C) who
are not at goal. Bempedoic acid and the bempedoic acid 180 mg +
ezetimibe 10 mg fixed dose combination tablets new drug
applications (NDAs) are also under regulatory review by the U.S.
Food and Drug Administration (FDA) with PDUFA dates of February
21st and 26th 2020.
Bempedoic Acid
Bempedoic acid is our lead, non-statin, oral,
once-daily, non-statin, LDL-C lowering therapeutic candidate,
currently under regulatory review by the FDA and EMA. With a
targeted mechanism of action, bempedoic acid is a first-in-class,
ATP Citrate Lyase (ACL) inhibitor that lowers LDL-C by reducing
cholesterol biosynthesis and up-regulating the LDL receptor.
Bempedoic acid has been observed to reduce high sensitivity
C-reactive protein (hsCRP), a key marker of inflammation associated
with cardiovascular disease. Completed Phase 3 studies conducted in
more than 4,000 patients, with over 2,600 patients treated with
bempedoic acid, demonstrated up to 18 percent placebo corrected
LDL-C lowering when used with moderate- and high-intensity statins
and 21 to 28 percent placebo corrected LDL-C lowering when used
with low dose or no background statin. Phase 3 results also show
bempedoic acid reduced hsCRP 19 to 31 percent. Pooled phase 3 data
highlighted that bempedoic acid reduced hemoglobin A1c (HbA1c) by
0.19% versus placebo in patients with diabetes (n=1,134) at 12
weeks.
Bempedoic Acid / Ezetimibe Fixed Dose
Combination Tablet
Through the complementary mechanisms of action of
inhibition of cholesterol synthesis (bempedoic acid) and inhibition
of cholesterol absorption (ezetimibe), the bempedoic acid /
ezetimibe fixed dose combination tablet is an oral, once-daily,
non-statin, LDL-C lowering therapeutic candidate, currently under
review by the FDA and EMA. Inhibition of ATP Citrate Lyase (ACL) by
bempedoic acid lowers LDL-C by reducing cholesterol biosynthesis
and up-regulating the LDL receptor. Inhibition of Niemann-Pick
C1-Like 1 (NPC1L1) by ezetimibe results in reduced absorption of
cholesterol from the gastrointestinal tract, thereby reducing
delivery of cholesterol to the liver. Phase 3 data demonstrated
that this combination significantly reduced LDL-C 38 percent from
baseline compared with placebo, as well as a 34 percent reduction
in high sensitivity C-reactive protein.
CLEAR Cardiovascular Outcomes
Trial
The effect of bempedoic acid on cardiovascular
morbidity and mortality has not yet been determined. Esperion
initiated a global cardiovascular outcomes trial (CVOT) to assess
the effects of bempedoic acid on the occurrence of major
cardiovascular events in patients with, or at high risk for,
cardiovascular disease (CVD) who are only able to tolerate less
than the lowest approved daily starting dose of a statin and
considered "statin averse." The CVOT — known as CLEAR
Cardiovascular Outcomes Trial — is an event-driven, global,
randomized, double-blind, placebo-controlled study that completed
enrollment in August 2019 of 14,032 patients with
hypercholesterolemia and high CVD risk at over 1,400 sites in 32
countries.
Esperion Therapeutics’ Commitment to
Patients with Hypercholesterolemia and Mixed
Dyslipidemia
High levels of LDL-C can lead to a build-up of fat
and cholesterol in and on artery walls (known as atherosclerosis),
potentially leading to cardiovascular events, including heart
attack or stroke. In the U.S., 96 million people, or more than 37
percent of the adult population, have elevated LDL-C. There are
approximately 18 million people in the U.S. with atherosclerotic
cardiovascular disease (ASCVD) who live with elevated levels of
LDL-C despite taking maximally tolerated lipid-modifying therapy —
including individuals considered statin averse — leaving them at
high risk for cardiovascular events1. In the United States, more
than 50 percent of ASCVD patients who are not able to reach their
LDL-C goals with statins alone need less than a 40 percent
reduction to reach their LDL-C threshold2.
Esperion's mission as the Lipid Management Company
is to deliver oral, once-daily, non-statin, medicines that
complement existing oral drugs to provide the additional LDL-C
lowering that these patients need.
Esperion Therapeutics
Through scientific and clinical excellence, and a
deep understanding of cholesterol biology, the experienced Lipid
Management Team at Esperion is committed to developing new LDL-C
lowering therapies that will make a substantial impact on reducing
global cardiovascular disease, the leading cause of death around
the world. For more information, please visit www.esperion.com
and follow us on Twitter
at https://twitter.com/EsperionInc.
Forward-Looking Statements
This press release contains forward-looking
statements that are made pursuant to the safe harbor provisions of
the federal securities laws, including statements regarding the
regulatory approval pathway for bempedoic acid tablet and the
bempedoic acid / ezetimibe fixed dose combination tablet, the
therapeutic potential of, and the clinical development plan for
bempedoic acid tablet and the bempedoic acid / ezetimibe fixed dose
combination tablet, including Esperion's timing, designs, plans for
announcement of results regarding its CLEAR Outcomes study and
other ongoing clinical studies for bempedoic acid tablet and the
bempedoic acid / ezetimibe combination fixed dose tablet, timing
for the review and approval of the NDAs and the MAAs, and
Esperion's expectations for the market for therapies to lower
LDL-C, including the market adoption of bempedoic acid tablet and
the bempedoic acid / ezetimibe fixed dose combination tablet, if
approved. Any express or implied statements contained in this press
release that are not statements of historical fact may be deemed to
be forward-looking statements. Forward-looking statements involve
risks and uncertainties that could cause Esperion's actual results
to differ significantly from those projected, including, without
limitation, delays or failures in Esperion’s studies, that positive
results from a clinical study of bempedoic acid may not be
sufficient for FDA or EMA approval or necessarily be predictive of
the results of future or ongoing clinical studies, that
notwithstanding the completion of Esperion’s Phase 3 clinical
development program for LDL-C lowering, the FDA or EMA may require
additional development in connection with seeking regulatory
approval, that existing cash resources may be used more quickly
than anticipated, and the risks detailed in Esperion's filings with
the Securities and Exchange Commission. Esperion disclaims any
obligation or undertaking to update or revise any forward-looking
statements contained in this press release, other than to the
extent required by law.
References 1 Esperion market
research on file: research project interviewing 350 physicians.
Esperion Therapeutics, Inc. Sept-Oct 2018. 2 Data on file:
analysis of NHANES database. Esperion Therapeutics, Inc. 2018.
Investor Contact: Alex Schwartz Esperion
734-249-3386 aschwartz@esperion.com
Media Contact: Ben Church Esperion 734-864-6774
bchurch@esperion.com
Media Contact: Elliot Fox W2Opure 212-257-6724
efox@purecommunications.com
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