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Leverkusen, Germany (pta024/08.01.2024/15:38) - The international biopharmaceutical company Biofrontera AG (ISIN: DE0006046113) announces that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has positively assessed the label extension for Ameluz®.
The label extension covers the photodynamic treatment of mild and moderate actinic keratoses (AK) with artificial daylight. Based on the CHMP's positive assessment, Biofrontera expects formal approval from the European Commission in February 2024.
"With this approval extension, our European sales organization will be able to start marketing Ameluz® in 2024 with an even broader application profile", commented Pilar de la Huerta, Chief Financial Officer of Biofrontera. "Photodynamic therapy with artificial daylight combines the benefits of the standard daylight therapy, which significantly reduces pain during treatment, with the controlled environment of a doctor's office, allowing patients to use Ameluz® with a daylight approach independently of the weather conditions. Ameluz® now offers a range of applications tailored to a wide variety of patient needs and environments. This success increases Ameluz® market potential, reinforcing its advantages compared with topical treatments."
The label extension was based on data from so-called IITs, clinical studies initiated by physicians and scientists with no commercial interest. In addition, Biofrontera conducted a comparative study with different light profiles, which showed that artificial daylight lamps also provide the necessary amount of energy for efficient photodynamic therapy.
Biofrontera is continuously working on innovative solutions to expand the treatment options for early forms of non-melanoma skin cancer in order to provide patients and treating physicians with a broad range of treatment options.
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emitter: Biofrontera AG
address: Hemmelrather Weg 201, 51377 Leverkusen
country: Germany
contact person: Investor Relations
phone: +49 (0) 214 87 63 20
e-mail: ir@biofrontera.com
website: www.biofrontera.com
ISIN(s): DE0006046113 (share)
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