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PTA-News: Biofrontera AG: Ameluz® obtains approval extension for use with artificial daylight in the EU and the UK

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Leverkusen, Germany (pta014/05.02.2024/10:15) - The Medicines and Healthcare Products Regulatory Agency (MHRA), the regulatory authority for medicinal products in the UK, has approved the extension of the marketing authorization for Ameluz® to include use with artificial daylight. In addition, the European Commission has formally approved the positive assessment by the European Medicines Agency for the extension of the marketing authorization in the EU, so that Biofrontera can now start marketing this extended area of use.

Since Brexit, the European Medicines Agency (EMA) is no longer responsible for drug approvals in the UK. Instead, it is now up to the MHRA to decide independently how medicinal products may be marketed in the UK. The granted approval applies exclusively to Great Britain at first but will be extended to the entire United Kingdom in the near future.

The extension of the approval to the use of artificial daylight opens up a wider range of treatment options for patients. In addition to conventional photodynamic therapy (PDT) with red light, individuals now have access to the benefits of low-pain daylight PDT without the limitations of natural light, weather conditions and time of day. In addition, the approved treatment protocol with Ameluz® can be optimally adapted to the needs of patients and the doctor's practice.

"The decision by the UK regulatory supports our decision to increase our activities in this country and help us to optimized patient care in the treatment of actinic keratoses. This new approval increases our market potential in the region, allowing our UK team to start the year with additional tools to expand our sales", commented Pilar de la Huerta, CFO of Biofrontera AG.


emitter: Biofrontera AG
address: Hemmelrather Weg 201, 51377 Leverkusen
country: Germany
contact person: Investor Relations
phone: +49 (0) 214 87 63 20

ISIN(s): DE0006046113 (share)
stock exchanges: regulated market in Dusseldorf, Frankfurt; free market in Munich, free market in Stuttgart; open market in Berlin, Tradegate

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