Brussels, 07/08/2001 (Agence Europe) - For the first time, two orphan medicinal products (i.e., intended to treat rare diseases) have received the Commission's approval to be placed on the market in the European Union. These are Fabrazyme and Replagal, two medicines containing the active substance a-Galactosidase, and intended to treat patients affected by Fabry's disease, rare and hereditary genetic disease affecting one person in 400,000 in the Union.
The two medicines were perfected by two different channels. Their marketing authorisation applications were scientifically evaluated by the European Medicine Evaluation Agency', whose positive opinions, issued on 29 March 2001, recommended that the Commission grant them marketing authorisation. Authorisation for placing on the market of a specific orphan product normally confers on its inventor ten years of market exclusivity. The fact that both products were authorised on the same day creates an unusual status of "co-exclusivity". Fabry's disease is due to a enzyme deficiency. It causes suffering, damage to the kidney and other organs and greatly reduced life expectancy for those afflicted.