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news.European regulators have granted orphan drug designation to MGI Pharma's Dacogen for injection for its potential use in the treatment of acute myeloid leukemia, or AML.
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Dacogen was previously approved by the FDA in May 2006 for the treatment of patients with myelodysplastic syndromes (MDS), a group of blood disorders which may lead to acute myeloid leukemia.
The orphan drug designation was established by the European Medicines Agency (EMEA) to encourage the development of treatments for rare, life threatening medical conditions that affect fewer than five in 10,000 people in the European Union (EU). This designation may also provide 10 years of market exclusivity in the EU following marketing approval. Dacogen was previously designated as an orphan drug by the EMEA for the MDS indication.
Dacogen is being co-developed by MGI Pharma and Janssen-Cilag, a Johnson & Johnson company. Janssen-Cilag companies are responsible for regulatory and commercial activities in all territories outside North America, while MGI Pharma retains responsibility for all activities in the US, Canada and Mexico.