Photo Source: Butterfly Children Charitable Foundation
The drug is known worldwide as Filsuvez (birch bark extract). It's indicated for treating cutaneous wounds in patients with dystrophic and junctional types of epidermolysis bullosa.
Previously, Filsuvez was approved for use by the EMA (European Medicines Agency), FDA (Food and Drug Administration in the USA), and MHRA in the United Kingdom (Medicines and Healthcare products Regulatory Agency).
In clinical trials, Filsuvez accelerated wound healing by 40-50% compared to standard dressings, though it only demonstrates efficacy with partial-thickness wounds (when at least the basal layer of skin remains intact).
This is the first specific agent for treating EB registered in Russia. Registration will enable unrestricted procurement.
For EB gene therapy, there's a promising agent Vyjuvek, it hasn't yet received registration in Russia, but since early 2025 has been procured by the state fund Krug Dobra for children through a special algorithm. The annual cost of this therapy is 60-90 million rubles per patient.
EB prevalence, according to national registries in developed countries, ranges from 10 to 50 per 1 million population.
In December, the Ministry of Health registered the first Russian generic of another orphan drug, Translarna (ataluren) from PTC Therapeutics, for treating children with Duchenne muscular dystrophy.
Source: Pharmvestnik
All information on this website is provided for informational purposes only and does not constitute medical advice. All medical procedures require prior consultation with a licensed physician. Treatment outcomes may vary depending on individual characteristics. We do not guarantee any specific results. Always consult a medical professional before making any healthcare decisions.