Filsuvez

birch bark extract

Table of contents

Opinion

On 22 April 2022, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Filsuvez1, intended for the treatment of epidermolysis bullosa (EB). The applicant for this medicinal product is Amryt Pharmaceuticals DAC.

Filsuvez will be available as a gel for cutaneous use. The active substance of Filsuvez is birch bark extract (as dry extract, refined) from Betula pendula Roth/Betula pubescens Ehrh. (equivalent to 0.5‑1.0 g birch bark), including 84‑95 mg triterpenes calculated as the sum of betulin, betulinic acid, erythrodiol, lupeol and oleanolic acid. It is thought to work by modulating inflammatory mediators and stimulating keratinocyte differentiation and migration, thereby promoting wound healing and closure.

The benefit of Filsuvez is its ability to promote healing of EB partial thickness wounds. The most common side effects are wound complications, application site reactions, wound infections, pruritus and hypersensitivity reactions.

The full indication is:

Treatment of partial thickness wounds associated with dystrophic and junctional epidermolysis bullosa (EB) in patients 6 months and older.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.


1This product was designated as an orphan medicine during its development. EMA will now review the information available to date to determine if the orphan designation can be maintained

 

Key facts

Name
Filsuvez
Agency product number
EMEA/H/C/005035
International non-proprietary name (INN) or common name
  • birch bark extract
Active substance
  • birch bark extract
Therapeutic area
Epidermolysis Bullosa Dystrophica
Epidermolysis Bullosa, Junctional
Orphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Date opinion adopted
22/04/2022
Company name
Amryt Pharmaceuticals DAC
Status
Positive
Application type
Initial authorisation

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