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.BioCryst Pharmaceuticals has said that Fodosine has been granted orphan status for the treatment of cutaneous T-cell lymphoma, by the European Medicines Agency.
Subscribe to our email newsletter
This is the second indication for which the European Medicines Agency (EMEA) has been granted orphan drug status to Fodosine following regulatory submissions by BioCryst's partner Mundipharma.
The EMEA has also granted orphan drug designation to Fodosine for the treatment of T-cell acute lymphoblastic leukemia (ALL).
In early 2006, BioCryst entered into a strategic collaboration with Mundipharma to develop and commercialize Fodosine in markets across Europe, Asia, Australia and certain neighboring countries for use in oncology.
The orphan designation is for drugs that may provide significant benefit to patients suffering from serious rare diseases. It provides 10 years of market exclusivity and also permits EMEA assistance in development and preparing a marketing application. Additionally an orphan product may qualify for a reduction in regulatory fees as well as a research grant.
Fodosine is currently being studied in clinical trials for indications including T-cell acute lymphoblastic leukemia (T-ALL), cutaneous T-cell lymphoma (CTCL), B-cell acute lymphoblastic leukemia (B-ALL) and chronic lymphocytic leukemia (CLL).