Allegheny General Hospital Patient Among First in U.S. to Receive New Drug for Treatment of ALS
Friday, August 11, 2017
Patient received this morning the first FDA-approved treatment for ALS in 22 years
PITTSBURGH, Pa. – An Allegheny General Hospital (AGH) patient is among the first in the United States to receive a newly approved medication for the treatment of amyotrophic lateral sclerosis (ALS). The patient, Rene Fogarty, of Turtle Creek received today the intravenous therapy, RADICAVA™ (edaravone), at the ALS Center at Allegheny Health Network – an ALS Association Certified Treatment Center of Excellence.
ALS, also known as Lou Gehrig’s disease, is a progressive neurodegenerative disease that affects nerve cells in the brain and spinal cord. Eventually, people with ALS lose the ability to initiate and control muscle movement, which often leads to total paralysis and death within two to five years of diagnosis. The Centers for Disease Control and Prevention estimates that approximately 12,000-15,000 Americans have ALS.
RADICAVA was approved by the FDA in May as the first new treatment option in 22 years for adult patients diagnosed with ALS. According to Mitsubishi Tanabe Pharma America, Inc., distributor of RADICAVA, approval was based on results of a six-month clinical trial in which the drug was shown to slow the decline in loss of physical function by 33 percent.
The only other treatment option that was available for ALS was approved by the FDA in 1995 after it had been shown to prolong the survival of patients taking the drug, called riluzole. According to Sandeep Rana, MD, Medical Director of the ALS Center at AHN, this treatment improves survival by three to six months on average.
“For an illness as relentless as ALS, it is a significant milestone to have a new treatment available which shows promise as an improvement upon what we currently have available to treat the disease. We are very hopeful that RADICAVA will help us to more effectively treat ALS and extend quality of life for our patients,” said Dr. Rana.
RADICAVA is an intravenous infusion administered with an initial treatment cycle of daily dosing for 14 days, followed by a 14-day drug-free period. Subsequent treatment cycles consist of dosing on 10 of 14 days, followed by 14 days drug-free.
Fogarty, who was recently diagnosed with ALS, will receive his treatment cycles at the ALS Center at AHN – the only ALS Association Certified Treatment Center of Excellence in western Pennsylvania. The ALS Association offers this designation for institutions that meet rigorous eligibility criteria, including: diversity of professional expertise in ALS; access to coordinated, multidisciplinary care; a strong, ongoing relationship with the local ALS Association chapter; and evidence of active participation in ALS research.
“RADICAVA is bringing hope to many who live with ALS and we are very encouraged that this drug is just the beginning of several more to come,” said Merritt Holland Spier, Executive Director of the ALS Association Western Pennsylvania Chapter. “It is the medical breakthroughs and innovative, groundbreaking care provided by clinics like the ALS Center of Excellence at Allegheny Health Network that are going to, one day, lead us to our end goal – a world without ALS.”
About Mitsubishi Tanabe Pharma America
Based in Jersey City, NJ, Mitsubishi Tanabe Pharma America, Inc., is a wholly-owned subsidiary of MTPC’s 100% owned U.S. holding company, Mitsubishi Tanabe Pharma Holdings America, Inc. Mitsubishi Tanabe Pharma America is dedicated to delivering innovative solutions that address the unmet medical needs of patients in the United States. It was established by MTPC to commercialize approved pharmaceutical products in the U.S. with plans to expand its product line through collaborations with partners.
About the ALS Association Western Pennsylvania Chapter
The ALS Association is the only national non-profit organization fighting Lou Gehrig’s disease on every front. By leading the way in global research, providing assistance for people living with ALS through a nationwide network of chapters, coordinating multidisciplinary care through certified and recognized treatment centers, and fostering government partnerships, the Association builds hope and enhances quality of life while aggressively searching for new treatments and a cure. For more information about the ALS Association, visit our website at www.cure4als.org.