17th Apr 2015 06:06
LONDON (Alliance News) - AstraZeneca PLC on Friday said the US Food and Drug Administration has granted orphan drug designation for its selumetinib treatment for uveal melanoma.
Uveal melanoma is a rare disease in which cancer cells form in the tissues of the eye, AstraZeneca said. The Orphan Drug Designation programme provides orphan status to drugs and biologics, which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US, it added.
"Uveal melanoma is a rare and devastating disease for which there are currently no effective treatment options once it spreads beyond the tissues of the eye. Selumetinib could potentially become the first effective treatment for these patients. The Orphan Drug Designation is an important regulatory advancement as we further our development plans for selumetinib in uveal melanoma," said Antoine Yver, AstraZeneca's head of oncology in its global medicines development unit.
By Sam Unsted; [email protected]; @SamUAtAlliance
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