Pfizer Submits New Pediatric Data For Lipitor(R) (Atorvastatin) To The European Medicines Agency (EMEA)

Main Category: Pediatrics / Children's Health
Also Included In: Regulatory Affairs / Drug Approvals;  Cholesterol
Article Date: 18 Nov 2009 - 15:00 PST

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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.

Pfizer's 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 EMEA's Paediatric Committee approved Pfizer's pediatric investigation plan to study the use of Lipitor in children aged 6 to under 18. This week, the Committee concluded that Pfizer's 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. It is not for those with liver problems. And it is not for women who are nursing, pregnant or may become pregnant.

Patients taking LIPITOR should tell their doctor if they feel any new muscle pain or weakness. This could be a sign of rare but serious muscle side effects. Patients should tell their doctor about all medications they take. This may help avoid serious drug interactions. Doctors should do blood tests to check your liver function before and during treatment and may adjust the dose. Common side effects are diarrhea, upset stomach, muscle and joint pain, and changes in some blood tests.

For additional product information, visit http://www.Lipitor.com.

1. Regulation (EC) No 1901/2006 of the European Parliament and of the Council on medicinal products for pediatric use, amended by Regulation (EC) No 1902/2006.

Source
Pfizer Inc