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EMA Backs Novartis Leukemia Drug

The European Medicines Agency (EMA) has followed in the footsteps of the USA’s FDA by approving Rydapt, a drug developed by Novartis to treat acute myeloid leukemia.

Rydapt was one of 11 medications that the EMA recommended for approval following the latest meeting of the Committee for Medicinal Products for Human Use (CHMP).

According to Reuters, Rydapt has multiple applications and in addition to treating leukemia, it can also be used as a therapy for adults with advanced systemic mastocytosis. The EMA noted that the drug can also be effective against systemic mastocytosis with associated haematological neoplasm and mast cell leukemia.

The news provider added that Rydapt was approved by the FDA back in April, with the wholesale cost of a two-week supply coming in at almost $7,500.

Getting the drug approved in Europe as well as the US is important for the firm, Reuters noted, as it is trying to rebuild its portfolio of cancer drugs after the patent on Gleevec expired early last year.

Other treatments approved by the EMA at its July meeting included Bavencio, which treats Merkel cell carcinoma, Xermelo, which is effective at treating carcinoid syndrome, and Lutathera, a therapy for gastro-entero-pancreatic neuroendocrine tumours.

In addition, Verkazia was reviewed under the organisation’s accelerated assessment mechanism and the EMA recommended providing the drug with a marketing authorisation. This therapy can be used to treat severe vernal keratoconjunctivitis in children and adolescents.

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