Esperion Announces New Drug Submissions in Canada for NEXLETOL® (bempedoic acid) and NEXLIZET® (bempedoic acid and ezetimibe) Treatments to Reduce LDL-C and Cardiovascular Risk

Rhea-AI Summary

Esperion (NASDAQ: ESPR) has submitted New Drug Submissions (NDSs) to Health Canada for NEXLETOL and NEXLIZET, once-daily oral non-statin medications for reducing LDL cholesterol and cardiovascular risk. These treatments target adults unable to take recommended statin therapy, with either established cardiovascular disease or high risk for CVD events. According to Canadian health data, approximately 2.6 million Canadian adults live with diagnosed heart disease, with 14 adults dying every hour from the condition.

Positive

• Expansion into Canadian market through new drug submissions
• Targeting large market opportunity with 2.6 million potential patients in Canada
• Products address unmet medical need for non-statin cholesterol treatments

Negative

• Safety concerns including risk of tendon rupture and hyperuricemia
• Multiple reported adverse reactions in clinical trials
• Competition with existing statin treatments in the market

Insights

Medical Research Analyst

The submission of NEXLETOL and NEXLIZET to Health Canada represents a significant market expansion opportunity for Esperion. With 2.6 million Canadian adults living with diagnosed heart disease, this creates a substantial potential market. The drugs' dual indication for both cardiovascular risk reduction and LDL-C lowering strengthens their market position.

The timing is strategic, following successful commercialization in other markets and positive cardiovascular outcomes data. However, the Canadian approval process typically takes 12-18 months, meaning revenue impact won't be immediate. The drugs' oral, non-statin nature provides a competitive advantage, particularly for statin-intolerant patients who represent about 10-15% of potential users.

The safety profile appears manageable, with known risks of hyperuricemia and tendon rupture that require monitoring but haven't significantly impacted adoption in other markets.

ANN ARBOR, Mich., Dec. 02, 2024 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced that it has filed New Drug Submissions (NDSs) to Health Canada for NEXLETOL and NEXLIZET, once-daily, accessible, oral non-statin medications that reduce low-density lipoprotein cholesterol (LDL-C) and cardiovascular risk.

"These submissions mark another pivotal milestone towards bringing our potentially lifesaving medications to the millions of patients around the world who need it,” said Sheldon Koenig, President and CEO of Experion. “Heart disease remains the number one cause of death globally, so we look forward to the opportunity to provide NEXLETOL and NEXLIZET as LDL cholesterol lowering and cardiovascular risk reduction treatment options for healthcare providers and patients in Canada."

According to the Public Health Agency of Canada (PHAC), heart disease is the second leading cause of death in Canada. Data from the Canadian Chronic Disease Surveillance System (CCDSS) from 2017-2018 showed that approximately 1 in 12 (or approximately 2.6 million) Canadian adults aged 20 and over live with diagnosed heart disease and every hour, approximately 14 Canadian adults aged 20 and over with diagnosed heart disease die.¹

INDICATION
NEXLIZET and NEXLETOL are indicated:

• The bempedoic acid component of NEXLIZET and NEXLETOL is indicated to reduce the risk of myocardial infarction and coronary revascularization in adults who are unable to take recommended statin therapy (including those not taking a statin) with:
  • established cardiovascular disease (CVD), or
  • at high risk for a CVD event but without established CVD.
• As an adjunct to diet:
  • NEXLIZET, alone or in combination with other LDL-C lowering therapies, to reduce LDL-C in adults with primary hyperlipidemia, including HeFH.
  • NEXLETOL, in combination with other LDL-C lowering therapies, or alone when concomitant LDL-C lowering therapy is not possible, to reduce LDL-C in adults with primary hyperlipidemia, including HeFH.

IMPORTANT SAFETY INFORMATION
NEXLIZET and NEXLETOL are contraindicated in patients with a prior hypersensitivity to bempedoic acid or ezetimibe or any of the excipients. Serious hypersensitivity reactions including anaphylaxis, angioedema, rash, and urticaria have been reported.

Hyperuricemia: Bempedoic acid, a component of NEXLIZET and NEXLETOL, may increase blood uric acid levels, which may lead to gout. Hyperuricemia may occur early in treatment and persist throughout treatment, returning to baseline following discontinuation of treatment. Assess uric acid levels periodically as clinically indicated. Monitor for signs and symptoms of hyperuricemia, and initiate treatment with urate-lowering drugs as appropriate.

Tendon Rupture: Bempedoic acid, a component of NEXLIZET and NEXLETOL, is associated with an increased risk of tendon rupture or injury. Tendon rupture may occur more frequently in patients over 60 years of age, in those taking corticosteroid or fluoroquinolone drugs, in patients with renal failure, and in patients with previous tendon disorders. Discontinue NEXLIZET or NEXLETOL at the first sign of tendon rupture. Consider alternative therapy in patients who have a history of tendon disorders or tendon rupture.

The most common adverse reactions in the primary hyperlipidemia trials of bempedoic acid, a component of NEXLIZET and NEXLETOL, in ≥2% of patients and greater than placebo were upper respiratory tract infection, muscle spasms, hyperuricemia, back pain, abdominal pain or discomfort, bronchitis, pain in extremity, anemia, and elevated liver enzymes.

Adverse reactions reported in ≥2% of patients treated with ezetimibe (a component of NEXLIZET) and at an incidence greater than placebo in clinical trials were upper respiratory tract infection, diarrhea, arthralgia, sinusitis, pain in extremity, fatigue, and influenza.

In the primary hyperlipidemia trials of NEXLIZET, the most commonly reported adverse reactions (incidence ≥3% and greater than placebo) observed with NEXLIZET, but not observed in clinical trials of bempedoic acid or ezetimibe, were urinary tract infection, nasopharyngitis, and constipation.

The most common adverse reactions in the cardiovascular outcomes trial for bempedoic acid, a component of NEXLIZET and NEXLETOL, at an incidence of ≥2% and 0.5% greater than placebo were hyperuricemia, renal impairment, anemia, elevated liver enzymes, muscle spasms, gout, and cholelithiasis.

Discontinue NEXLIZET or NEXLETOL when pregnancy is recognized unless the benefits of therapy outweigh the potential risks to the fetus. Because of the potential for serious adverse reactions in a breast-fed infant, breastfeeding is not recommended during treatment with NEXLIZET or NEXLETOL.

Report pregnancies to Esperion Therapeutics, Inc. Adverse Event reporting line at 1-833-377-7633.

Please see full Prescribing Information for NEXLIZET and NEXLETOL.

Esperion Therapeutics

At Esperion, we discover, develop, and commercialize innovative medicines to help improve outcomes for patients with or at risk for cardiovascular and cardiometabolic diseases. The status quo is not meeting the health needs of millions of people with high cholesterol – that is why our team of passionate industry leaders is breaking through the barriers that prevent patients from reaching their goals. Providers are moving toward reducing LDL-cholesterol levels as low as possible, as soon as possible; we provide the next steps to help get patients there. Because when it comes to high cholesterol, getting to goal is not optional. It is our life’s work. For more information, visit esperion.com and esperionscience.com and follow us on X at 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 marketing strategy and commercialization plans, current and planned operational expenses, future operations, commercial products, clinical development, including the timing, designs and plans for the CLEAR Outcomes study and its results, plans for potential future product candidates, financial condition and outlook, including expected cash runway, and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “suggest,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions. 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, the net sales, profitability, and growth of Esperion’s commercial products, clinical activities and results, supply chain, commercial development and launch plans, the outcomes and anticipated benefits of legal proceedings and settlements, and the risks detailed in Esperion’s filings with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and 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.

Esperion Contact Information:
Investors:
Alina Venezia
investorrelations@esperion.com
(734) 887-3903

Media:
Tiffany Aldrich
corporateteam@esperion.com
(616) 443-8438

¹ https://www.canada.ca/en/public-health/services/publications/diseases-conditions/heart-disease-canada.html. Accessed Nov. 19, 2024.

FAQ

What new drug submissions has Esperion (ESPR) filed in Canada?

Esperion has filed New Drug Submissions (NDSs) to Health Canada for NEXLETOL (bempedoic acid) and NEXLIZET (bempedoic acid and ezetimibe), which are once-daily oral medications for reducing LDL cholesterol and cardiovascular risk.

What is the market size for Esperion's (ESPR) drugs in Canada?

According to the Canadian Chronic Disease Surveillance System, approximately 2.6 million Canadian adults aged 20 and over live with diagnosed heart disease, representing the potential market for these treatments.

What are the main safety concerns for Esperion's (ESPR) NEXLETOL and NEXLIZET?

The main safety concerns include risk of hyperuricemia (increased blood uric acid levels), tendon rupture, and various adverse reactions including upper respiratory tract infection, muscle spasms, and elevated liver enzymes.