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5-aminolaevulinic acid (Ameluz)

Advice

Following a resubmission:

5 aminolaevulinic acid (as hydrochloride) (Ameluz®) is accepted for use within NHS Scotland.

Indication under review: Treatment of superficial and / or nodular basal cell carcinoma (BCC) unsuitable for surgical treatment due to possible treatment-related morbidity and / or poor cosmetic outcome in adults.

In a phase III study of patients with BCC, up to two cycles of photodynamic therapy (PDT) with 5 aminolaevulinic acid gel was non-inferior to PDT with an alternative photosensitising agent for the primary endpoint, complete clearance, defined as clearance of all treated lesions, assessed visually at 12 weeks after the last PDT.

Drug Details

Drug Name: 5-aminolaevulinic acid (Ameluz)
SMC Drug ID: 1260/17
Manufacturer: Biofrontera Bioscience GmbH
Indication: Treatment of superficial and / or nodular basal cell carcinoma (BCC) unsuitable for surgical treatment due to possible treatment-related morbidity and / or poor cosmetic outcome in adults.
BNF Category:
Submission Type: Resubmission
Status: Accepted
Date Advice Published: 12 February 2018

Archived Advice

Full submission 7 August 2017

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