10 August 2015 - Taro Pharmaceutical Industries Ltd. announced today 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. 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.
“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.
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