Athenex Announces FDA Acceptance for Filing of U.S. NDA for Tirbanibulin Ointment in Actinic Keratosis
“We are delighted by the FDA’s acceptance for filing of the NDA for tirbanibulin ointment, which was submitted in late December 2019,” said Dr.
The tirbanibulin ointment NDA includes data from two positive pivotal Phase III studies of tirbanibulin ointment 1% in actinic keratosis. As previously reported, the studies achieved the primary endpoint of 100% clearance of the AK lesions on Day 57 within the face or scalp treatment areas. Safety results showed that tirbanibulin ointment was well tolerated, with few adverse events.
Athenex and Almirall, S.A. entered into a license agreement in which Athenex granted Almirall an exclusive license to research, develop and commercialize tirbanibulin ointment in the
About the Phase III Clinical Program of Tirbanibulin Ointment
Two double-blind, randomized, vehicle-controlled, parallel group, multi-center studies (KX-AK-003 and KX-AK-004) were designed to support the registration of tirbanibulin ointment as field therapy for AK of the face or scalp. The studies enrolled a total of 702 patients across 62 sites in the US. Tirbanibulin ointment 1% or vehicle (randomized 1:1) was self-administered to 25 cm2 of the face or scalp encompassing 4-8 typical AK lesions, once daily for 5 consecutive days.
About Actinic Keratosis
Actinic Keratosis is a common skin condition that is induced through ultra-violet light damage, resulting in patches of thick, scaly or crusty skin. Left untreated, the lesions may progress to squamous cell carcinoma and consequently treatment by a dermatologist is recommended. AK is the most common pre-cancerous condition in dermatology and affects more than 55 million Americans, and accounts for between 14-29% of dermatologist visits in the
Founded in 2003,
Except for historical information, all of the statements, expectations, and assumptions contained in this press release are forward-looking statements. These forward-looking statements are typically identified by terms such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “foresee,” “goal,” “guidance,” “intend,” “likely,” “may,” “plan,” “potential,” “predict,” “preliminary,” “probable,” “project,” “promising,” “seek,” “should,” “will,” “would,” and similar expressions. Actual results might differ materially from those explicit or implicit in the forward-looking statements. Important factors that could cause actual results to differ materially include: the development stage of our primary clinical candidates and related risks involved in drug development, clinical trials, regulation, manufacturing and commercialization; our reliance on third parties for success in certain areas of Athenex’s business; our history of operating losses and need to raise additional capital to continue as a going concern; our ability to integrate CIDAL’s assets into our existing operations; competition; intellectual property risks; risks relating to doing business internationally and in
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Corporate Development and Investor Relations
Source: Athenex, Inc.