Taro Pharmaceutical Industries Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved Keveyis™ (dichlorphenamide) 50 mg Tablets for the treatment of primary hyperkalemic and hypokalemic periodic paralysis, a group of rare hereditary disorders that cause episodes of muscle weakness or paralysis.[1] Keveyis is the first medicine approved by the FDA for the treatment of primary periodic paralysis, which is estimated to affect approximately 5,000 people in the United States.[2]
Periodic paralyses are a group of rare hereditary disorders that cause episodes of muscle weakness or paralysis. Types of periodic paralyses are differentiated by criteria including underlying genetic mutations and changes in blood-potassium during attack. Hypokalemic and hyperkalemic are two common types of periodic paralyses.[1]
“The approval of Keveyis demonstrates the importance of industry, scientific researchers, patient advocates and the FDA working together to identify and bring to market a treatment for primary periodic paralysis,” said Kal Sundaram, Chief Executive Officer of Taro. “Taro is proud of its commitment to this community, which has been waiting for a new, effective treatment option for many years. We thank the FDA for their continued partnership in making this important day a reality.”
Taro expects Keveyis will be available for patients during the third quarter of 2015. The company has created the Keys2Care program which will provide a suite of patient support services to ensure people diagnosed with periodic paralysis can receive treatment with Keveyis as soon as possible. As part of this program, the company is working with Diplomat Pharmacy, Inc., a specialty pharmacy, to offer access and support to patients who are prescribed Keveyis and their caregivers.
“Because of the very-rare nature of periodic paralysis, it is not unusual for patients to go years before receiving an accurate diagnosis,” said Robert Griggs, MD, principal investigator and professor, Department of Neurology, University of Rochester Medical Center. “For those living with often debilitating symptoms, the approval of Keveyis is both an important and much needed treatment advance and an opportunity for greater disease awareness and understanding, something that has long been a challenge for these people.”
References:
[1] National Institute of Neurological Disorders and Stroke. NINDS Familial Periodic Paralyses Information Page. http://www.ninds.nih.gov/disorders/periodic_paralysis/periodic_paralysis.htm. National Institute of Neurological Disorders and Stroke. Published March 12, 2012. Accessed July 1, 2015.
[2] inVentiv Health, United Health Claims Database Analysis, October 2014.
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