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Novartis' LysaKare therapy, Univar genetic disorder drug backed for EU approval

The European Medicines Agency recommended the approval of two new therapies in May, including radiation protection treatment LysaKare, developed by Novartis AG unit Advanced Accelerator Applications SA.

The agency's Committee for Medicinal Products for Human Use, or CHMP, gave a positive opinion for LysaKare to treat patients undergoing a radioactive therapy with lutetium oxodotreotide. LysaKare protects the kidneys from radiation during the treatment.

CHMP also backed the approval of Univar Inc.'s Cufence for a rare genetic disorder. Univar is developing Cufence to treat Wilson's disease, an inherited condition that causes copper to accumulate in vital organs like the liver and brain. Serious complications include liver failure, persistent neurological problems and kidney damage.

The European Commission granted an orphan designation to Cufence in October 2003. The EMA's Committee for Orphan Products will again review the drug to determine its orphan status based on available data.

The CHMP adopted a negative opinion for Xyndari, a medicine developed by Emmaus Life Sciences Inc. to treat sickle cell disease, a group of inherited red blood cell disorders in which red blood cells die early.

The committee also decided against recommending TLC Biopharmaceuticals BV's Doxolipad. The CHMP was reviewing the breast and ovarian cancer treatment for the second time after adopting a negative opinion for the drug in February.