Anacor Pharmaceuticals submits tavaborole NDA to FDA for treatment of onychomycosis

Anacor Pharmaceuticals (NASDAQ:ANAC) announced today that on July 26, 2013 it submitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tavaborole, its drug candidate for the topical treatment of onychomycosis. Onychomycosis is a fungal infection of the nail and nail bed that affects approximately 35 million people in the United States.

“Anacor was founded eleven years ago based on the promise of boron chemistry. Tavaborole is the first drug in our pipeline to reach this important milestone, and I'd like to acknowledge and thank the entire Anacor team for their hard work, dedication and persistence.”

"The submission of the NDA is a significant milestone for Anacor," said David Perry, Anacor's Chief Executive Officer. "Anacor was founded eleven years ago based on the promise of boron chemistry. Tavaborole is the first drug in our pipeline to reach this important milestone, and I'd like to acknowledge and thank the entire Anacor team for their hard work, dedication and persistence."

Anacor announced earlier this year that tavaborole achieved statistically significant and clinically meaningful results on all primary and secondary endpoints in two Phase 3 pivotal studies of tavaborole to treat onychomycosis topically without concomitant debridement. The only currently FDA-approved topical treatment for onychomycosis is approved with concomitant nail debridement, and currently approved oral therapies have been associated with rare but serious safety issues.

Comments

The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
Post a new comment
Post

While we only use edited and approved content for Azthena answers, it may on occasions provide incorrect responses. Please confirm any data provided with the related suppliers or authors. We do not provide medical advice, if you search for medical information you must always consult a medical professional before acting on any information provided.

Your questions, but not your email details will be shared with OpenAI and retained for 30 days in accordance with their privacy principles.

Please do not ask questions that use sensitive or confidential information.

Read the full Terms & Conditions.

You might also like...
Repurposing cancer drug to prevent organ damage in infectious diseases