Antigenics Inc. on Tuesday said that the US Food and Drug Administration (FDA) has deemed the company’s late-stage investigational cancer vaccine Oncophage an orphan drug for metastatic melanoma. The FDA orphan drug designation was designed to encourage the development of therapies for conditions affecting fewer than 200,000 people in the US.
The designation entitles the sponsor to aid with the development program, tax breaks, waivers from certain regulatory fees and 7 years of additional marketing exclusivity if the product eventually is approved.
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