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The Food and Drug Administration has granted Orphan Drug status to liposomal encapsulated paclitaxel easy to use (LEP-ETU) for the treatment of ovarian cancer. LEP-ETU, made by Insys Therapeutics, is a new formulation of paclitaxel combined with liposomes, designed to maintain or enhance the anti-tumor properties of paclitaxel, while offering the advantages of a shorter infusion time, no required premedication, fewer side effects, and possibly greater effectiveness if higher doses can be delivered without an increase in side effects.

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The Orphan Drug designation-to encourage development of drugs in the diagnosis, prevention, or treatment of a medical condition affecting fewer than 200,000 people in the U.S.-grants a product market exclusivity for a seven-year period if the sponsor complies with certain FDA specifications, as well as tax credits and prescription drug user fee waivers. The designation does not, though, shorten the duration of the regulatory review and approval process.


"By entrapping the paclitaxel with liposomes, we believe our LEP-ETU formulation could potentially have reduced toxicity, while maintaining or enhancing efficacy of the cancer-fighting paclitaxel. We are currently evaluating next steps with respect to this drug product candidate," said Michael L. Babich, President and Chief Executive Officer of the drug's manufacturer, Insys Therapeutics, Inc.


A Phase I trial for the drug is currently ongoing.