– Bempedoic Acid is an Oral, Once-daily ATP
Citrate Lyase (ACL) Inhibitor that Reduces Cholesterol and Fatty
Acid Synthesis in the Liver –– February 21, 2020 PDUFA Target Date
Goal for Bempedoic Acid and February 26, 2020 PDUFA Target Date
Goal for the Bempedoic Acid / Ezetimibe Combination Tablet –– The
FDA also communicated there is no current plan to hold an advisory
committee meeting to discuss the applications –
Esperion (Nasdaq: ESPR) announced today that the U.S. Food and Drug
Administration (FDA) has accepted both New Drug Applications for
bempedoic acid and the bempedoic acid / ezetimibe combination
tablet for filing and regulatory review. Bempedoic acid and the
bempedoic acid / ezetimibe combination tablet were developed to be
complementary, cost-effective, convenient, once-daily, oral
therapies for the treatment of patients with elevated low-density
lipoprotein cholesterol (LDL-C) who need additional LDL-C lowering
despite the use of currently accessible therapies.
The PDUFA (Prescription Drug User Fee Act) goal date for the
completion of the bempedoic acid NDA review is set for February 21,
2020, and the PDUFA goal date for completion of the bempedoic acid
/ ezetimibe combination tablet NDA review is set for February 26,
2020. These dates are consistent with our expectations and reflect
the standard review period. The FDA has communicated that there is
no current plan to hold an advisory committee meeting to discuss
the applications.
“It is exceptional that our New Drug Applications for both
bempedoic acid and bempedoic acid / ezetimibe combination tablet
have been accepted for filing. The acceptances validate the
extraordinary effort and high-quality submissions of our Lipid
Management Team and brings our once-daily, oral bempedoic
acid-based therapies one step closer to the physicians and patients
who will benefit from them,” said Tim M. Mayleben, president and
chief executive officer of Esperion. “Our team of Lipid Management
Experts remains focused on serving the needs of the millions of
patients in the US not at their LDL-C goal despite currently
available therapies.”
Esperion's Global Pivotal Phase 3 LDL-C Lowering Program
to Support FDA and EMA Submissions
Esperion completed its global, pivotal, Phase 3 clinical
development program and announced positive cumulative results
in October 2018. The program evaluated the safety,
tolerability and consistent, complementary LDL-C-lowering efficacy
of bempedoic acid and the bempedoic acid / ezetimibe combination
tablet in patients with atherosclerotic cardiovascular disease
(ASCVD), or who are at a high risk for ASCVD, with
hypercholesterolemia who continue to have elevated levels of LDL-C
despite the use of maximally-tolerated statins and ezetimibe,
leaving them at high risk for cardiovascular events. The program
included five studies totaling approximately 4,000 patients, four
for bempedoic acid and one for the bempedoic acid / ezetimibe
combination tablet.
- Two pivotal studies evaluated bempedoic acid (Studies 1 and 2)
in 3,008 patients with ASCVD on maximally-tolerated statins, with
top-line results reported in May 2018 and October 2018,
respectively;
- Two pivotal studies evaluated bempedoic acid (Studies 3 and 4)
in 613 patients with ASCVD, or at a high risk for ASCVD, considered
statin averse, with top-line results reported in May 2018
and March 2018, respectively;
- One pivotal study evaluated the bempedoic acid / ezetimibe
combination tablet (053 Study) in 382 patients with ASCVD, or at
high risk for ASCVD, on maximally tolerated statins, with top-line
results reported in August 2018.
Bempedoic acid and the bempedoic acid / ezetimibe combination
tablet new drug applications are under regulatory review by the
U.S. FDA and the marketing authorization applications for these
product candidates are under review by the European Medicines
Agency (EMA).
Bempedoic Acid
Bempedoic acid is our lead, non-statin, complementary, orally
available, once-daily, LDL-C lowering therapy. With a targeted
mechanism of action, bempedoic acid is a first-in-class, ATP
Citrate Lyase (ACL) inhibitor that reduces cholesterol biosynthesis
and lowers LDL-C by up-regulating the LDL receptor. Similar to
statins, bempedoic acid also reduces 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, have produced an
additional 18 percent LDL-C lowering when used with moderate- and
high-intensity statins and 28 percent LDL-C lowering when used with
no background statin.
Bempedoic Acid / Ezetimibe 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
combination tablet is a non-statin, orally available, once-daily,
LDL-C lowering therapy. Inhibition of ATP Citrate Lyase (ACL) by
bempedoic acid reduces cholesterol biosynthesis and lowers LDL-C by
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, which in turn upregulates the
LDL receptors. Phase 3 data demonstrated that this combination
results in a 29 percent LDL-C lowering when used with maximally
tolerated statins, a 44 percent LDL-C lowering when used with no
background statin (post-hoc analysis), and a 34 percent reduction
in high sensitivity C-reactive protein (hsCRP).
CLEAR Outcomes
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 Outcomes — is an event-driven, global, randomized,
double-blind, placebo-controlled study expected to enroll
approximately 12,600 patients with hypercholesterolemia and high
CVD risk at over 1,000 sites in approximately 30 countries.
Esperion's Commitment to Patients with
Hypercholesterolemia
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 events. 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
threshold.
Esperion's mission as the Lipid Management Company is to deliver
once-daily, oral therapies that complement existing oral drugs to
provide the additional LDL-C lowering that these patients need.
The Lipid Management Company
Esperion is the Lipid Management Company passionately committed
to developing and commercializing convenient, complementary,
cost-effective, once-daily, oral therapies for the treatment of
patients with elevated LDL-C. 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. Bempedoic acid and the
bempedoic acid / ezetimibe combination tablet are targeted
therapies that have been shown to significantly lower elevated
LDL-C levels in patients with hypercholesterolemia, including
patients inadequately treated with current lipid-modifying
therapies. 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 the bempedoic acid / ezetimibe combination
tablet and bempedoic acid and the therapeutic potential of,
clinical development plan for, the bempedoic acid / ezetimibe
combination tablet and bempedoic acid, including Esperion's timing,
designs, plans and announcement of results regarding its global
cardiovascular outcomes trial and other ongoing clinical studies
for bempedoic acid and the bempedoic acid / ezetimibe combination
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 and the
bempedoic acid / ezetimibe combination tablet, if approved, and the
expected upcoming milestones described in this press release. 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.
Investor Contact: Alex Schwartz Esperion
734-249-3386 aschwartz@esperion.com
Media Contact: Elliot Fox W2Opure 212-257-6724
efox@purecommunications.com
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