Date: 2017-01-31
Type of information: Granting of a Market Authorisation in the EU
Product name: Ameluz®
Compound: 5-aminolevulinic acid
Therapeutic area: Cancer - Oncology - Dermatological diseases
Action mechanism:
Company: Biofrontera Bioscience (Germany)
Disease: actinic keratosis of mild to moderate severity on the face and scalp (Olsen grade 1 to 2) and of field cancerization
Latest news:
- • On 15 December 2016, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for Ameluz®. The CHMP adopted a new indication as follows: “Treatment of superficial and/or nodular basal cell carcinoma unsuitable for surgical treatment due to possible treatment-related morbidity and/or poor cosmetic outcome in adults.”
The full indications for Ameluz will be as follows: “Treatment of actinic keratosis of mild to moderate severity on the face and scalp (Olsen grade 1 to 2) and of field cancerization in adults.
Treatment of superficial and/or nodular basal cell carcinoma unsuitable for surgical treatment due to
possible treatment-related morbidity and/or poor cosmetic outcome in adults.”
- • On 21 July 2016, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion
recommending a change to the terms of the marketing authorisation for Ameluz®. The CHMP adopted an extension to the existing indication as follows: Treatment of actinic keratosis of mild to moderate severity on the face and scalp (Olsen grade 1 to 2) and of field cancerization.” The label extension for this topical prescription drug for actinic keratosis now include the treatment of field cancerization. The decision was based on the Phase III trial ALA AKCT007 conducted in Germany. The 86-patient study assessed field-directed treatment using combination Ameluz® plus medical lamp BF-RhodoLED® for photodynamic therapy (PDT) against placebo. The study demonstrated that 91% of patients treated with Ameluz® were completely cleared after a maximum of two treatments, compared to only 22% complete clearance in patients treated with placebo. Over the course of one year, full clearance was sustained in 63% of patients treated with Ameluz®.
In addition to the positive assessment of Ameluz® for field cancerization from the CHMP, Biofrontera Biosciences has filed for an additional label extension of Ameluz® for the treatment of non aggressive basal cell carcinoma (BCC), including superficial and nodular BCC.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization:
UE authorization: 2017-01-31
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE:
OTC status:
Other news:
Is general: Yes
