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Astellas blood cancer drug Xospata, 6 others backed for EU approval

The European Medicines Agency recommended approving seven new therapies in September, including Astellas Pharma Inc.'s blood cancer treatment Xospata.

Xospata, or gilteritinib, is intended to treat adult patients whose acute myeloid leukemia with the FLT3 mutation has returned or is unresponsive to treatment. Acute myeloid leukemia is a fast-growing cancer in which too many immature white blood cells known as myeloblasts are found in the bone marrow and blood.

The agency's Committee for Medicinal Products for Human Use, or CHMP, gave a positive opinion for AstraZeneca PLC's Qtrilmet for treating type 2 diabetes mellitus.

The CHMP also backed the approval of Rhokiinsa, Aerie Pharmaceuticals Inc.'s eye drop for glaucoma or ocular hypertension — a condition that causes high pressure within the eyes.

The EMA also granted positive opinion to Plethora Solutions Ltd's Senstend, a therapy for treating premature ejaculation in adult men.

Plethora Solutions' submission for Senstend was an informed consent application, meaning it makes use of data from the records of an already-authorized medicine. The reference product for the drug is Fortacin, another drug by the London-based company for the same indication.

Also receiving the CHMP's backing were three generic blood cancer medicines: Accord Healthcare Ltd.'s Arsenic Trioxide Accord, for acute promyelocytic leukemia; Fresenius Kabi Deutschland Gmbh's Bortezomib Fresenius Kabi, for multiple myeloma and mantle cell lymphoma; and Orphelia Pharma SA's Ivozall, for treating children with acute lymphoblastic leukemia.

Eight medicines were recommended by the regulator for extended indications, including Roche Holding AG and Sanofi's Dupixent for treating adults with chronic rhinosinusitis with nasal polyposis.

A combination of Merck KGaA's Bavencio and Pfizer Inc.'s Inlyta was backed for extended approval as the initial treatment for patients with advanced renal cell carcinoma.

Eli Lilly and Co.'s Trulicity was recommended for extended approval to treat adults with insufficiently controlled type 2 diabetes mellitus in addition to diet and exercise.

The CHMP recommended the broader use of GlaxoSmithKline PLC's lupus drug Benlysta to include children 5 years and older.

The EMA also recommended Novartis AG's eye medicine Lucentis for proliferative diabetic retinopathy; Zentiva k.s.' Docetaxel Zentiva, formerly known as Docetaxel Winthrop, for hormone-sensitive prostate cancer that has spread to other parts of the body; Celltrion Inc.'s Remsima, a biosimilar of Johnson & Johnson's arthritis drug Remicade; and Aventis Pharma SA's prostate cancer therapy Taxotere.