Fidest – Agenzia giornalistica/press agency

Quotidiano di informazione – Anno 33 n° 335

Almirall announces EMA acceptance for filing of Marketing Authorization Application (MAA) for tirbanibulin in actinic keratosis

Posted by fidest press agency su mercoledì, 4 marzo 2020

Almirall, S.A. (ALM) today announced that the European Medicines Agency’s (EMA) has accepted the filing of the Marketing Authorization Application (MAA) for tirbanibulin, also known as ALM14789, for the treatment of 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, there is a risk that the lesions can progress to squamous cell carcinoma and therefore, should be treated by a dermatologist.“If approved by the EMA, tirbanibulin could be an important step towards significantly improved treatment of actinic keratosis both in Europe, as it has the potential to provide a marked improvement of the quality of life for patients suffering from this disease. Almirall’s commitment to unmet needs in dermatology, in partnership with Athenex’s expertise in drug development in this space, will significantly transform the approach towards this disease”, commented Volker Koscielny, MD, Chief Medical Officer of Almirall.
EMA filing is based on the analysis of two Phase III studies (KX01-AK-003 and KX01-AK-004) that evaluated the efficacy and safety of tirbanibulin ointment 1% (10 mg/g) in adults with actinic keratosis on the face or scalp. Tirbanibulin met the primary endpoint of complete clearance of actinic keratosis lesions at day 57 within the face or scalp treatment areas, each study achieving statistical significance (p<0.0001) on this endpoint. Almirall and Athenex, Inc. (NASDAQ: ATNX) entered into a strategic partnership in December 2017 to further develop and commercialize KX2-391 for the treatment of actinic keratosis and other skin conditions in the United States and Europe, including Russia. Athenex is responsible for conducting all preclinical and clinical studies up to first FDA approval. Almirall will employ its expertise to support the development in Europe and also to commercialize the product in the licensed territories. It is estimated that peak sales of tirbanibulin will be in excess of €250 million.


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