FDA Grants Pediatric Exclusivity For TOPAMAX®

Main Category: Pediatrics / Children's Health
Also Included In: Regulatory Affairs / Drug Approvals;  Clinical Trials / Drug Trials
Article Date: 26 Jul 2008 - 1:00 PST

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Ortho-McNeil Neurologics, a division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., announced that the U.S. Food and Drug Administration (FDA) has granted pediatric exclusivity for TOPAMAX® (topiramate), based on studies submitted in response to a Written Request by the FDA to investigate the use of TOPAMAX in pediatric patients aged 1 to 24 months with partial onset seizures.

In addition to granting pediatric exclusivity, the FDA is continuing its review of the application to determine the safety and efficacy of TOPAMAX in this patient population. Based on the data submitted, no indication is sought for this age group.

A recent court decision confirmed the validity of the TOPAMAX patent, which is set to expire in September 2008. However, this grant will extend the period of exclusivity through March 2009. TOPAMAX is not approved for use in pediatric patients aged 1 to 24 months.

TOPAMAX® is indicated as initial monotherapy in patients 10 years of age and older with partial onset seizures or generalized tonic-clonic seizures. It also is indicated as adjunctive therapy for adults and children (aged two and above) with partial onset seizures or generalized tonic-clonic seizures, and in adults and children as adjunctive therapy for the treatment of seizures associated with Lennox-Gastaut syndrome. TOPAMAX® is indicated in adults for the prophylaxis of migraine headache.

Important Safety Information: Serious risks associated with TOPAMAX include lowered bicarbonate levels in the blood resulting in an increase in the acidity of the blood (metabolic acidosis). Symptoms could include hyperventilation (rapid, deep breathing), tiredness, loss of appetite, irregular heartbeat or changes in the level of alertness. Call your doctor immediately if you get these symptoms. Your doctor may want to do simple blood tests. Chronic, untreated metabolic acidosis may increase the risk for kidney stones or bone disease.

Other serious risks include decreased sweating, increased body temperature, kidney stones, sleepiness, dizziness, confusion, difficulty concentrating, and increased eye pressure (glaucoma). Call your doctor immediately if you have any decrease in vision or eye pain. These problems can lead to blindness if not treated right away.

More common side effects are tingling in arms and legs, loss of appetite, tiredness, nausea, diarrhea, taste change and weight loss.

Headquartered in Titusville, NJ, Ortho- McNeil Neurologics, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., focuses exclusively on providing solutions that improve neurological health. The company currently markets products for Alzheimer's disease, epilepsy and acute and preventive migraine treatment. In conjunction with internal and external research partners, Ortho-McNeil Neurologics continues to explore new opportunities to develop solutions for unmet health care needs in neurology.

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) is a wholly-owned subsidiary of Johnson & Johnson, the world's most broadly-based producer of health care products. J&JPRD is headquartered in Raritan, N.J., and has facilities throughout Europe, the United States and Asia. J&JPRD is leveraging drug discovery and drug development in a variety of therapeutic areas, including CNS, Internal Medicine and Oncology, to address unmet medical needs worldwide. More information can be found at http://www.jnjpharmarnd.com.

(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the Company's expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 30, 2007. Copies of this Form 10-K, as well as subsequent filings, are available online at http://www.sec.gov, http://www.jnj.com or on request from Johnson & Johnson. The Company does not undertake to update any forward-looking statements as a result of new information or future events or developments.)