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

June 20, 2019 Off By BusinessWire

MONTGOMERY, Ala.–(BUSINESS WIRE)–Remove the three paragraphs with headings INDICATIONS AND USAGE, PRIMARY
HYPERLIPIDEMIA AND MIXED DYSLIPIDEMIA, and LIMITATIONS OF USE
from release issued June 18, 2019.

The corrected release reads:

KOWA PHARMACEUTICALS AMERICA, INC. RECEIVES PEDIATRIC INDICATION AND
SIX-MONTH PEDIATRIC EXCLUSIVITY FOR LIVALO^®(PITAVASTATIN)

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

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 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.

________________________________

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

ⁱⁱ 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