Trial Profile
A 52-Week Open-Label Extension and Safety Study of Pitavastatin in High-Risk Hyperlipidaemia in Childhood, P/266/2011, P/267/2011, P/268/2011
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 21 Aug 2019
Price :
$35
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At a glance
- Drugs Pitavastatin (Primary)
- Indications Hyperlipidaemia; Hyperlipoproteinaemia type IIa
- Focus Adverse reactions; Registrational
- Acronyms PASCAL 402
- Sponsors Kowa
- 18 Jun 2019 According to a Kowa Pharmaceuticals America media release, the approval of LIVALO (pitavastatin) for pediatric patients was granted in conjunction with fulfillment of FDAs 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.
- 18 Jun 2019 According to a Kowa Pharmaceuticals America media release, the pediatric label indication for LIVALO is supported by a 12-week, double-blind, placebo-controlled trial (n=82, pediatric patients 8 to 16 years of age with heterozygous familial hypercholesterolemia (HeFH), EudraCT2011-004964-32), and a 52-week open-label trial (n=85, pediatric patients with HeFH, EudraCT2011-004983-32).
- 18 Jun 2019 According to a Kowa Pharmaceuticals America media release, 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).