Kowa Pharmaceuticals America, Inc. Receives Pediatric Indication and Six-Month Pediatric Exclusivity for LIVALO® (pitavastatin)

MONTGOMERY, Ala.--(BUSINESS WIRE)-- Kowa Pharmaceuticals America, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved the cholesterol-lowering drug LIVALO^® (pitavastatin) for pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH) to reduce elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C) and apolipoprotein B (Apo B). The approval was granted in conjunction with fulfillment of FDA’s Written Request to obtain pediatric information on pitavastatin and provides a 6-month pediatric exclusivity with regard to the U.S. patent protection for LIVALO.

LIVALO is an HMG-CoA reductase inhibitor that is currently approved in the U.S. as an adjunctive therapy to diet in adult patients with primary hyperlipidemia or mixed dyslipidemia to reduce elevated TC, LDL-C, Apo B and triglycerides (TG), and to increase high-density lipoprotein cholesterol (HDL-C).

The pediatric label indication for LIVALO is supported by a 12-week, double-blind, placebo-controlled trial in 82 pediatric patients 8 to 16 years of age with HeFH, and a 52-week open-label trial in 85 pediatric patients with HeFH.

Heterozygous familial hypercholesterolemia (HeFH) is a genetic disorder stemming from a DNA variant for familial hypercholesterolemia (FH) that is passed down from one affected parent. HeFH renders the body unable to remove LDL-C from the blood, causing dangerously high cholesterol levels, which can lead to premature heart disease, heart attack, or stroke if left untreated. HeFH is one of the most common genetic diseases, affecting at least 1 in 250 individuals.ⁱ

“Kowa is dedicated to providing safe and effective treatments for those suffering from serious cardiometabolic diseases, which includes a significant number of children in the U.S. with hereditary high cholesterol,” said Ben Stakely, Chairman, CEO and President of Kowa Pharmaceuticals America, Inc. “With the new pediatric indication for pitavastatin, we are pleased to be able to support a broader population of people affected by high cholesterol, which represents an ongoing public health issue.”

About High Cholesterol

High cholesterol is defined as total cholesterol ≥240 mg/dL based on guidelines from the National Institutes of Health (NIH). When cholesterol levels rise, thick, hard buildup can occur in the artery wall, narrowing arteries and slowing down or even blocking blood flow to the heart and brain. High cholesterol is a major risk for stroke and heart disease, the leading causes of death in the United States.ⁱⁱ It can be lowered through a healthy diet, exercise, and by taking a medication (like a statin) as recommended by a physician.

About LIVALO

LIVALO is an HMG-CoA reductase inhibitor (statin).

INDICATIONS AND USAGE

Drug therapy should be one component of multiple-risk-factor intervention in individuals who require modifications of their lipid profile. Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol only when the response to diet and other nonpharmacological measures has been inadequate.

PRIMARY HYPERLIPIDEMIA AND MIXED DYSLIPIDEMIA

LIVALO (pitavastatin) is indicated as an adjunctive therapy to diet in adult patients with primary hyperlipidemia or mixed dyslipidemia to reduce elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), and to increase high-density lipoprotein cholesterol (HDL-C) (1), and in pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH) to reduce elevated TC, LDL-C, and Apo B.

LIMITATIONS OF USE

• Doses of LIVALO greater than 4 mg once daily were associated with an increased risk for severe myopathy in premarketing clinical studies. Do not exceed 4-mg, once-daily dosing of LIVALO
• The effect of LIVALO on cardiovascular morbidity and mortality has not been determined
• LIVALO has not been studied in Fredrickson Type I, III, and V dyslipidemias

Important Safety Information

Indications and Usage

LIVALO is a HMG-CoA reductase inhibitor indicated as an adjunctive therapy to diet in:

• Adult patients with primary hyperlipidemia or mixed dyslipidemia to reduce elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), and to increase high-density lipoprotein cholesterol (HDL-C).
• Pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH) to reduce elevated TC, LDL-C, and Apo B.

Limitations of Use

• The effect of LIVALO on cardiovascular morbidity and mortality has not been determined.

Contraindications

• Known hypersensitivity to product components.
• Coadministration with cyclosporine.
• Active liver disease, with may include unexplained persistent elevations in hepatic transaminase levels.
• Pregnancy.
• Lactation.

Warnings and Precautions

• Myopathy and Rhabdomyolysis: Risk factors include age 65 and greater, renal impairment, inadequately treated hypothyroidism, concomitant use of certain drugs, and higher doses of LIVALO. LIVALO is contraindicated in patient taking cyclosporine and not recommended in patients taking gemfibrozil. The following drugs when used concomitantly with LIVALO may also increase the risk of myopathy and rhabdomyolysis: lipid-modifying dosages of niacin (>1 grams/day), fibrates, and colchicine. Discontinue LIVALO if markedly elevated CK levels occur or myopathy is diagnosed or suspected. Temporarily discontinue LIVALO in patients experiencing an acute or serious condition at high risk of developing renal failure secondary to rhabdomyolysis; e.g., sepsis; shock; severe hypovolemia; major surgery; trauma; severe metabolic, endocrine, or electrolyte disorders; or uncontrolled epilepsy. Inform patients of the risk of myopathy and rhabdomyolysis when starting or increasing the LIVALO dosage. Instruct patients to promptly report any unexplained muscle pain, tenderness or weakness particularly if accompanied by malaise or fever.
• Immune-Mediated Necrotizing Myopathy (IMNM): There have been rare repots of IMNM, an autoimmune myopathy, associated with statin use. IMNM is characterized by: proximal muscle weakness and elevated serum creatine kinase, which persist despite discontinuation of statin treatment; muscle biopsy showing necrotizing myopathy without significant inflammation; and improvement with immunosuppressive agents.
• Hepatic Dysfunction: Increases in serum transaminases can occur. Rare postmarketing reports of fatal and non-fatal hepatic failure have occurred. Consider liver enzyme testing before initiating therapy and as clinically indicated thereafter. If serous hepatic injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs, promptly discontinue LIVALO.
• Increases in HbA1c and Fasting Serum Glucose Levels: Increases of each have been reported with statins, including LIVALO. Optimize lifestyle measures, including regular exercise, maintaining a healthy body weight, and making healthy food choices.

Adverse Reactions

In short-term controlled studies, the most frequent adverse reactions reported by ≥2% of patients treated with LIVALO 1 mg, 2 mg, and 4 mg, respectively, and at a rate ≥ placebo were back pain (3.9%, 1.8%, 1.4% vs 2.9%), constipation (3.6%, 1.5%, 2.2% vs 1.9%), diarrhea (2.6%, 1.5%, 1.9%), myalgia (1.9%, 2.8%, 3.1% vs 1.4%), and pain in extremity (2.3%, 0.6%, 0.9% vs 1.9%). Other serious adverse reactions include rhabdomyolysis, immune-mediated necrotizing myopathy, hepatic dysfunction, and increases in HbA1c and fasting serum glucose. In adult HIV-infected patients with dyslipidemia, the safety profile of LIVAO was generally consistent with that observed in the short-term controlled studies described above. In pediatric patients with HeFH, the safety profile was similar to that observed in the adult population. This is not a complete listing of all reported adverse events.

For additional information, please see the full Prescribing Information at https://www.livalorx.com/.

© Kowa Pharmaceuticals America, Inc. (2016) - LIV-MT-3461

Kowa Company, Ltd. and Kowa Pharmaceuticals America, Inc.

Kowa Company, Ltd. (Kowa) is a privately held, multinational company headquartered in Nagoya, Japan. Established in 1894, Kowa is actively engaged in various business fields including the trading of textiles, machinery, and construction materials, in addition to the manufacturing and sales of medicines, medical equipment, and energy saving products. Kowa’s pharmaceutical division is focused on research and development for cardiovascular therapeutics (dyslipidemia, type 2 diabetes and atherosclerosis), ophthalmology and anti-inflammatory agents. The company’s flagship product, LIVALO^® (pitavastatin), is approved in 46 countries around the world.

Kowa Pharmaceuticals America, Inc., headquartered in Montgomery, AL, is focused primarily in the area of cardiometabolic diseases. Established in September 2008, Kowa Pharmaceuticals America focuses its efforts on the successful commercialization of its current and near-term portfolio of pharmaceutical products, and business development activities. For more information about Kowa Pharmaceuticals America, visit https://www.kowapharma.com/.

LIVALO is a registered trademark of the Kowa group of companies.

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