Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Biotech firm Mapreg has reported that the European Commission has granted its lead compound, MAP4343, orphan drug status for the treatment of spinal cord injury and has entered the compound in the European Community register of orphan drugs.
Subscribe to our email newsletter
This decision follows a favorable opinion from the Orphan Drugs Committee of the European Medicines Evaluation Agency (EMEA). The orphan drug status granted by the EMEA facilitates the development of products designed to treat rare diseases, which would not otherwise be profitable enough because of the small number of patients involved.
Orphan status gives a product 10 years exclusivity in a particular therapeutic indication in the European market, including France, Germany, Italy, Spain and the UK. Orphan drug status also enables a company to obtain scientific assistance and advice from the EMEA for demonstrating the product’s quality, safety and efficacy during the entire development cycle.
Etienne-Emile Baulieu, president of Mapreg, said: “The granting of orphan drug status in the EU is an important step for Mapreg and for the future benefit of patients having suffered a spinal cord injury. The results on animal models are without parallel and we want to move forward to initiate the first clinical trials.”