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news.Sweden-based Oasmia Pharmaceutical has received orphan drug designation from the FDA for its Paclical for the treatment of ovarian cancer.
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The orphan drug designation provides Oasmia with seven year market exclusivity on the indication when the pharmaceutical is approved.
The designation is based on the hypothesis that Paclitaxel is safer than Taxol. Oasmia Pharmaceutical is conducting a Phase III study comparing the use of Paclical to Taxol in patients with ovarian cancer. A safety objective is to show the superiority of hypersensitivity reactions.
Julian Aleksov, CEO of Oasmia, said: “This designation shows that the FDA has a great confidence in the company and our product. The US is one of the most important markets for Paclical. This decision improves the possibilities for the product.”