EMA Recommends Approval of 11 Drugs

CHMP recommended the following:

• Conditional marketing authorization was given to Lartruvo, for the treatment of adults with advanced soft tissue sarcoma.
• Marketing authorization for Ibrance, for the treatment of locally advanced or metastatic breast cancer.
• Conditional marketing authorization for Ninlaro (ixazomib) for the treatment of multiple myeloma.
• Approval of Glyxambi (empagliflozin/linagliptin) for the treatment of type 2 diabetes.
• Approval of Parsabiv (etelcalcetide) for the treatment of secondary hyperparathyroidism.
• Marketing authorization of SomaKit-TOC (edotreotide) an orphan drug for the diagnosis of gastro-entero-pancreatic neuroendrocrine tumors.
• Positive opinion for Chenodeoxycholic acid sigma-tau (chenodeoxycholic acid) for the treatment of cerebrotendinous xanthomatosis. 

CHMP also recommended the approval of four generic drugs: Ivabradine JensenR (ivabradine) and Ivabradine Zentiva (ivabradine) to treat angina pectoris and heart failure, Emtricitabine/ Tenofovir disoproxil Zentiva (emtricitabine/tenofovir disoproxil) to treat HIV infection, and Granpidam (sildenafil) for the treatment of patients with pulmonary arterial hypertension.

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