Athenex Announces FDA Acceptance for Filing of U.S. NDA for Tirbanibulin Ointment in Actinic Keratosis



Treatment for Actinic Keratosis

Athenex Announces FDA Acceptance for Filing of U.S. NDA for Tirbanibulin Ointment in Actinic Keratosis

BUFFALO, N.Y., March 09, 2020 (GLOBE NEWSWIRE) – Athenex, Inc. (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, announced today that the U.S. Food and Drug Administration (FDA) has completed its filing review and determined that the Company’s New Drug Application (NDA) for tirbanibulin ointment (formerly known as KX2-391 or KX-01 ointment) for the treatment of actinic keratosis (AK) is sufficiently complete to permit a substantive review. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of December 30, 2020.  Additionally, the FDA has communicated that it is not currently planning on holding an advisory committee to discuss the application.

“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. Rudolf Kwan, Chief Medical Officer of Athenex. “It marks an important step towards bringing this valuable treatment option to AK patients and we look forward to working with the FDA during the review process towards potential approval.”

Dr. Johnson Lau, Chairman and Chief Executive Officer of Athenex, also stated, “Tirbanibulin is the first compound to come out of our discovery program, and this represents a significant milestone as the first NDA filing for our company. We would like to thank our team for their hard work and dedication, especially in making the submission ahead of schedule. We are excited to continue collaborating with our partner, Almirall, to prepare for the potential commercial launch of tirbanibulin ointment for AK in the U.S.”

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 U.S. and European countries, including Russia. Almirall will employ its expertise to support the development in Europe and commercialize the product in the defined territories. 

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 U.S.1

About Athenex, Inc.
Founded in 2003, Athenex, Inc. is a global clinical stage biopharmaceutical company dedicated to becoming a leader in the discovery, development and commercialization of next generation drugs for the treatment of cancer. Athenex is organized around three platforms, including an Oncology Innovation Platform, a Commercial Platform and a Global Supply Chain Platform. The Company’s current clinical pipeline is derived from four different platform technologies: (1) Orascovery, based on P-glycoprotein inhibitor, (2) Src kinase inhibition, (3) T-cell receptor-engineered T-cells (TCR-T), and (4) Arginine deprivation therapy. Athenex’s employees worldwide are dedicated to improving the lives of cancer patients by creating more active and tolerable treatments.  Athenex has offices in Buffalo and Clarence, New York; Cranford, New Jersey; Houston, Texas; Chicago, Illinois; Hong Kong; Taipei, Taiwan; multiple locations in Chongqing, China; Manchester, UK; Guatemala City, Guatemala and Buenos Aires, Argentina. For more information, please visit

Forward-Looking Statements
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 China, including the impact of public health epidemics such as the coronavirus; the uncertainty of when, if at all, we will be able to resume full API production operations in Chongqing; and the other risk factors set forth from time to time in our SEC filings, copies of which are available for free in the Investor Relations section of our website at or upon request from our Investor Relations Department. All information provided in this release is as of the date hereof and we assume no obligation and do not intend to update these forward-looking statements, except as required by law.


1. E. Stockfleth et al. Physician perceptions and experience of current treatment in actinic keratosis. JEADV 2015, 29, 298–306

Source: Athenex, Inc.

Posted: March 2020

tirbanibulin FDA Approval History

Leave a Reply

Your email address will not be published. Required fields are marked *