Anacor Pharmaceuticals, Inc.’s (ANAC) Kerydin (tavaborole) topical solution, 5% received approval in the U.S. for the topical treatment of onychomycosis of the toenails. Kerydin is the first oxaborole antifungal to receive FDA approval for this indication. Approval came several days ahead of the FDA action date of Jul 29.
Kerydin is applied to the infected toenail once daily for 48 weeks with no debridement required during the treatment period. The drug has low systemic absorption and showed no systemic side effects in pivotal studies.
Onychomycosis is a progressive, recurring fungal infection of the nail and nail bed. According to Podiatry Today, onychomycosis affects nearly 35 million people in the U.S. However, only 5−6 million patients are diagnosed by podiatrists.
Our Take
The FDA approval for Kerydin is an important milestone for Anacor. Kerydin is the first approved drug for the company. It is easier-to-use than the therapies currently available in the market. Anacor intends to launch Kerydin in the U.S. by September.
Meanwhile, Anacor is working on developing its pipeline. Anacor’s topical anti-inflammatory candidate, AN2728, is in phase III studies for the topical treatment of mild-to-moderate atopic dermatitis.
Some drugs approved for the treatment of atopic dermatitis include Elidel and Protopic. We note that Sanofi (SNY) and Regeneron Pharmaceuticals, Inc. (REGN) are evaluating dupilumab for treating patients suffering from moderate-to-severe atopic dermatitis. Dupilumab is expected to enter phase III program by year end.
Anacor carries a Zacks Rank #3 (Hold). A better-ranked stock in the health care sector is Synergy Pharmaceuticals, Inc. (SGYP), carrying a Zacks Rank #1 (Strong Buy).
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