On 23 February 2011, orphan designation (EU/3/10/845) was
granted by the European Commission to Birken GmbH, Germany, for
dry extract from birch bark (DER 0.1-0.2:1), extraction solvent
n-heptane 95% (V/V) for the treatment of epidermolysis bullosa.
- What is epidermolysis bullosa? Epidermolysis bullosa is an
inherited disease of the skin that mainly affects babies and
children, in which the outer layer of the skin, the epidermis,
separates from the inner layer, the dermis. This makes the skin
very fragile and causes severe blistering and scarring. The
disease is caused by abnormalities in the genes responsible for
the production of the proteins that make the skin strong and
elastic, such as collagen. Epidermolysis bullosa is a disease
that is debilitating in the long term and may be life
threatening, mainly because of the severe blistering, which
results in poor quality of life and reduced life expectancy. -
What is the estimated number of patients affected by the
condition? At the time of designation, epide