NAPSR news: FDA Approves Anacor Pharma's KERYDIN (Tavaborole) to treat Onychomycosis of the Toenails

WASHINGTON - July 9, 2014 - PRLog -- Anacor Pharmaceuticals, Inc. made the official announcement on July 8, 2014, that the U.S. Food and Drug Administration (FDA) approved the New Drug Application for KERYDIN™ (tavaborole). KERYDIN™  is administered as a topical solution, 5%, and is the first oxaborole antifungal approved for onychomycosis of the toenails. Onychomycosis is a recurring fungal infection of the nail and nail bed affecting approximately 35 million people in the United States, but only 5-6 million have been diagnosed by a physician, according to Podiatry Today.

"We are pleased to announce the FDA approval of KERYDIN, which provides an important new topical treatment option for the millions of people in the United States who are infected with onychomycosis of the toenails," said Paul Berns, Chief Executive Officer of Anacor Pharmaceuticals. "We expect to launch KERYDIN in the U.S., either alone or with a partner, as early as the end of this quarter."

"Onychomycosis is one of the most common diseases diagnosed and treated by podiatrists. Historically, a large number of patients with onychomycosis would choose not to treat their infection," said Warren Joseph, D.P.M., lower extremity Infectious Diseases consultant at Roxborough Memorial Hospital in Philadelphia, Pennsylvania. "With the approval of KERYDIN, physicians can now offer patients a safe, effective and easy-to-use topical treatment for their onychomycosis of the toenail, which I think will be well-received by patients."

"I am very excited about the release of this therapy for an infection that is very difficult to treat," said Boni Elewski, M.D., Vice Chair of Clinical Affairs and Professor of Dermatology at the University of Alabama at Birmingham. "KERYDIN will offer patients a new, safe and effective treatment option for onychomycosis."

"KERYDIN was designed to be convenient for patients to use and has demonstrated efficacy in the treatment of the fungal infection, thus allowing growth of new uninfected nail," stated Vince Ippolito, Chief Commercial Officer of Anacor Pharmaceuticals. "In market research conducted by Anacor, KERYDIN's product profile was received with great enthusiasm by the participating physicians and we believe this response demonstrates the need for a safe topical treatment for onychomycosis of the toenails."

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