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

FOR IMMEDIATE RELEASE

MONTGOMERY, AL, June 20, 2019 — 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).


Important Safety Information for LIVALO® (pitavastatin) tablets

Indications and Usage

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

Limitations of Use

Contraindications

Warnings and Precautions

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% vs 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 LIVALO 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 or visit LivaloHCP.com.

© Kowa Pharmaceuticals America, Inc. (2019) - LIV-RA-0119 PI V-05-2019


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.


National Association for Rare Disorders, Familial Hypercholesterolemia: https://rarediseases.org/rare-diseases/familial-hypercholesterolemia/. Accessed on May 22, 2019.

Centers for Disease Control and Prevention, National Center for Health Statistics. Underlying Cause of Death 1999-2013 on CDC WONDER Online Database, released 2015. Data are from the Multiple Cause of Death Files, 1999-2013, as compiled from data provided by the 57 vital statistics jurisdictions through the Vital Statistics Cooperative Program: http://wonder.cdc.gov/ucd-icd10.html. Accessed on Feb 3, 2015.

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