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www.fdanews.com/articles/200658-elevar-therapeutics-strikes-licensing-deal-in-europe-for-ovarian-cancer-drug
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Elevar Therapeutics Strikes Licensing Deal in Europe for Ovarian Cancer Drug

December 30, 2020

Elevar Therapeutics has entered into a licensing arrangement with the Inceptua Group to sell Apealea (paclitaxel micellar) in Europe, a treatment used with chemotherapy drug carboplatin for treatment of a specific form of ovarian cancer, primary peritoneal cancer and fallopian tube cancer.

Apealea, which the European Commission approved in 2018, is the first nonCremophor-based formulation of paclitaxel authorized for ovarian cancer in Europe. Cremophor is used to improve the solubility of paclitaxel, but it has been linked with serious side effects, including anaphylactic reactions, hyperlipidemia and peripheral neuropathy.

Elevar said it will seek U.S. marketing approval for Apealea, which has already received the FDA’s Orphan Drug designation.

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