Marketing Authorization for TOOKAD® granted by European Commission
Steba Biotech announce that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion on the company’s Marketing Authorisation Application (MAA) on 14 September 2017. The European Commission has granted Marketing Authorization for TOOKAD® (padeliporfin), used as part of a focal, Vascular-Targeted Photodynamic therapy (VTP), on 10 November 2017.
TOOKAD® is approved for use in the 28 countries of the European Union (EU) and European Economic Area (EEA) countries (Iceland, Liechtenstein, and Norway).
The regulatory filing for TOOKAD® is supported by two years of data from its phase III, active-controlled, randomized study in which TOOKAD® met its two primary objectives.
TOOKAD is indicated as monotherapy for adult patients with previously untreated, unilateral, low-risk adenocarcinoma of the prostate with a life expectancy ≥ 10 years and:
TOOKAD® focal therapy is a new therapeutic option that reduces the overall toxicity such as erectile dysfunction and urinary incontinence in comparison with active surveillance and radical therapy.
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