The European Commission, following the positive opinion of the European Medicines Agency (EMEA), has granted the designation of orphan drug to Human Plasminogen, made by Kedrion, in the form of eye drops used for the treatment of ligneous conjunctivitis.
Ligneous conjunctivitis is a rare form of conjunctivitis which may lead to blindness and is characterized by the fact that a large membranous lesion replaces the normal palpebral mucosa.
This pathology, for which no effective treatment is presently available, has an estimated average incidence of 1,6/1.000.000 people worldwide, i.e. largely inferior to the one considered necessary for orphan designation (the parameters are: incidence of less than 5/10.000 people in Europe, no treatment authorised in the EU and evidence of the effectiveness of the proposed drug).
The Company is now working on the preparation of a clinical protocol for Plasminogen, which will be submitted to the EMEA by the end of the year. EMEA will not only follow up the studies to ensure the product’s safety and effectiveness but will also evaluate the application for the marketing authorisation in all European Union countries, a mandatory procedure for any new orphan product.
