Investing.com -- Shares in Maryland-based United Therapeutics Corporation (NASDAQ:UTHR) closed more than 2% higher on Tuesday after the U.S. Food and Drug Administration approved its drug to help treat an aggressive form of a rare cancer that typically occurs in children under the age of five.
The FDA's approval of United Therapeutics' Unituxin marked the first time the agency has authorized drug treatment for high-risk neuroblastoma, a rare cancer that forms in immature nerve cells. Neuroblastomas usually originate in the adrenal glands, but can quickly spread to the chest, abdomen or in tissue near the spine. The FDA expedited the trial process by granting Unituxin priority review, which lowered the assessment period by four months in comparison with normal trials.
“Unituxin fulfills a critical need by providing a treatment option that prolongs survival in children with high-risk neuroblastoma," said Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.
Neuroblastoma occurs in roughly one out of 100,000 children in the United States, according to the National Cancer Institute (NCI). There are an estimated 650 new cases involving neuroblastoma's each year. In spite of the aggressive treatments, there is a 40-50% chance of long-term survival, the NCI found.
Following the announcement, shares in United Therapeutics rose 2.12% or 3.40 to 163.84. Since late-August, United Therapeutics is up more than $70 a share.
"We are grateful for the FDA's thorough review and collaboration on this program, and we look forward to expanding our research efforts in the area of pediatric oncology," said Dr. Roger Jeffs, United Therapeutics' President and Co-Chief Executive Officer.
Treatment of neuroblastomas for families of affected children can exceed six-figure levels.