Pfizer Submits New Pediatric Data For Lipitor® (Atorvastatin) To The European Medicines Agency (EMEA)
Business Wire, Nov 18, 2009
Filing Follows EMEAs Conclusion that Pfizers Program Studying
the Use of Lipitor in Children with High Cholesterol is in Compliance
with its Requirements
NEW YORK — Pfizer Inc (NYSE:PFE) announced it has submitted pediatric data for
Lipitor (atorvastatin) to the European Medicines Agency (EMEA). Pfizer
has also developed a new chewable form of Lipitor, including a
pediatric-appropriate 5 mg dose, which is part of this submission.
Approximately one in 500 people suffer from an inherited disorder,
called Familial Hypercholesterolemia (FH), which causes high levels of
LDL-cholesterol (bad? cholesterol) and an increased risk of heart
disease. Pfizer hopes that additional scientific data about the use of
atorvastatin in children with FH will help improve diagnosis and
treatment of the condition.
arthritis pain relief Pfizers data submission reflects a European Union (EU) initiative
encouraging research, development and availability of medicines for
children. All authorized medicines undergo extensive testing in both
laboratories and clinical trials prior to their approval. However, there
is often limited information available about pediatric use. One 2005
study found that more than half of all medicines in Europe have not been
tested and authorized for use in children.
In 2007, the EU enacted a new Regulation requiring pharmaceutical
companies to research their medicines for use by children. The
requirements cover new medicines, and existing ones under certain
circumstances. In 2008, the EMEAs Paediatric Committee approved
Pfizers pediatric investigation plan to study the use of Lipitor in
children aged 6 to under 18. This week, the Committee concluded that
Pfizers pediatric atorvastatin program has been implemented in
compliance with its requirements.
To encourage companies to make the investments necessary to conduct
these trials, the EU also created certain incentives, including the
availability of a six-month extension to an existing patent extension,
also known as a supplementary protection certificate (SPC). If Pfizer
fulfils all further requirements of the EU Paediatric Medicines
Regulation, Pfizer will be eligible and intends to apply for an
additional six months of patent/SPC protection for Lipitor in certain EU
countries.
Pfizer is committed to improving the lives of all adults and children at
risk of cardiovascular disease and will continue to work closely with
the EMEA and other regulatory authorities to help address areas of unmet
medical need and reduce health inequalities. Lipitor has been approved
for use in children (aged 10 to 17 years old) with heterozygous familial
hypercholesterolemia in the United States since 2002.
Important U.S. Prescribing Information
LIPITOR is a prescription medicine that is used along with a low-fat
diet. It lowers the LDL (”bad” cholesterol) and triglycerides in your
blood. It can raise your HDL (”good” cholesterol) as well. LIPITOR can
lower the risk for heart attack, stroke, certain types of heart surgery,
and chest pain in patients who have heart disease or risk factors for
heart disease such as age, smoking, high blood pressure, low HDL, or
family history of early heart disease.
LIPITOR can lower the risk for heart attack or stroke in patients with
diabetes and risk factors such as diabetic eye or kidney problems,
smoking, or high blood pressure.
LIPITOR is not for everyone
Nov 18, 2009
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