The US FDA has turned down an application for orphan drug status for Dusa Pharmaceuticals' preventive treatment for some forms of skin cancer, Levulan. The agency only awards orphan drug status to potential therapies that address US-based patient populations under 200,000. Dusa sought the status for the treatment of cutaneous squamus cell carcinomas.
Levulan is a light-sensitive ointment that is applied to certain precancerous patches of skin. Without orphan drug status for the treatment, Dusa will be denied the incentives that go along with it (such as a period of market exclusivity).
CANCER TYPE(S)
Skin cancer (cutaneous squamus cell carcinoma)
TREATMENT TYPE(S)
Topical ointment
By Ross Bonander
Source
TherapeuticsDaily.com
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