FDA Grants The Medicines Company Pediatric Exclusivity For Angiomax(R)

Main Category: Pediatrics / Children's Health
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 19 Jun 2009 - 7:00 PST

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The Medicines Company (NASDAQ: MDCO) announced that the U.S. Food and Drug Administration (FDA) has granted pediatric exclusivity for Angiomax® (bivalirudin), based on studies submitted in response to a Written Request by the FDA to investigate the use of Angiomax in pediatric patients aged birth to 16-years old. With this additional six months of exclusivity, the FDA will not authorize commercialization of generic versions of bivalirudin prior to September 2010.

"The FDA's decision responds to the critical need for effective anticoagulant treatments for children undergoing intravascular heart procedures," said Rolando Zamora, MD, Director of Pediatric Interventional Cardiology, Methodist Children's Heart Institute, San Antonio, TX. "There have been very few studies of anticoagulation in children, especially in those undergoing these critical heart procedures, and current agents have major disadvantages in the pediatric population. Angiomax could have an important impact on this young patient population," said Ziyad Hijazi, MD, Director of the Center for Congenital and Structural Heart Disease, Professor of Pediatrics and Internal Medicine, Rush University Medical Center, IL.

The submission was based on a prospective, open-label, multi-center, single arm study evaluating Angiomax as a procedural anticoagulant in the pediatric population undergoing intravascular procedures for congenital heart disease. The trial enrolled 110 patients (less than 16 years of age), including 11 neonates (less than 30 days) and 33 infants/toddlers (30 days - less than 2 years), undergoing multiple types of catheter-based treatment for their congenital heart abnormalities. Patients were given a 0.75 mg/kg bolus loading dose and a 1.75 mg/kg/hr infusion for the duration of the procedure.

Study outcomes suggest that the pharmacokinetic (PK) and pharmacodynamic (PD) response of Angiomax in the pediatric population is predictable and behaves in a manner similar to that in adults. Using weight based dosing, as currently approved in adults, Angiomax safely provided the expected anticoagulant effect in the pediatric population undergoing intravascular procedures for congenital heart disease.

"These data, similar to previous studies in adults, once again demonstrate that Angiomax is safe and allows for predictable anticoagulation across a broad spectrum of patients undergoing percutaneous procedures, including pediatric patients with life threatening heart conditions," said John Kelley, President and Chief Operating Officer of The Medicines Company. "While pediatric trials can be challenging, we are committed to providing critical care medicines that reliably and cost-effectively deliver meaningful clinical advantages for patients in need."

These data have been presented at this year's Society for Cardiac Angiography and Interventions (SCAI) annual meeting in Las Vegas, NV. The data will also be presented this month at the Pediatric & Adult Interventional Cardiac Symposium (PICS-ACIS) in Cairns, Australia.

The FDA may grant a drug additional marketing exclusivity if a company conducts clinical studies in certain pediatric populations at the written request of the FDA. The granting of additional marketing exclusivity reflects the FDA's determination that the study fairly responded to the FDA's Written Request. This provision is designed to encourage further investigation into the unmet medical needs of the pediatric population and was established under the Best Pharmaceuticals for Children Act of 2002.

About Angiomax

Angiomax is a direct thrombin inhibitor with a naturally reversible mechanism of action and 25 minute half-life. In clinical trials, treatment with Angiomax resulted in improved clinical outcomes with significantly reduced rates of major bleeding compared to heparin plus GPI across the entire spectrum of risk in patients undergoing PCI and numerically lower rates of 1-year mortality in patients undergoing PCI.

In the United States, Angiomax with provisional GPI is indicated in patients undergoing angioplasty, also called PCI, and in patients with, or at risk of, heparin-induced thrombocytopenia and thrombosis syndrome (HIT/HITTS) undergoing PCI. In addition, Angiomax is indicated for use as an anticoagulant in patients with UA undergoing percutaneous transluminal coronary angioplasty (PTCA). Angiomax is intended for use with aspirin. The most common adverse events for Angiomax in clinical trials comparing Angiomax and heparin were back pain, pain, nausea, headache, and hypotension. The incidence of these adverse events was comparable in both the Angiomax and heparin groups in these trials. An unexplained fall in blood pressure or hematocrit, or any unexplained symptom, should lead to serious consideration of a hemorrhagic event and cessation of Angiomax administration. Angiomax is contraindicated in patients with active major bleeding or hypersensitivity to Angiomax or its components. Please see full prescribing information available at http://www.angiomax.com.

Source
The Medicines Company