Development of orphan medicines receives important judicial ruling

On 22 March 2018, the European General Court confirmed that a new medicinal product containing the same active substance as a company’s existing medicinal product may be entitled to its own period of orphan exclusivity.

The ruling follows a legal challenge by Shire Pharmaceuticals Ireland against the European Medicines Agency (EMA). The EMA refused to grant orphan designation status to the Shire medicinal product, Idursulfase-IT for the treatment of mucopolysaccharidosis, type II.

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Published 23. March 2018 in News EU