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EU medicines agency recommends approval of Novartis leukemia drug Rydapt

Written by: | no-reply@reuters.com | Dated: Friday, July 21st, 2017

ZURICH (Reuters) – A European Medicines Agency (EMA) panel recommended on Friday approval of a new Novartis drug to be used against a tough-to-cure form of blood cancer as the Swiss drugmaker makes headway on refreshing its oncology portfolio.

The EMA’s Committee for Medicinal Products for Human Use (CHMP) backed Rydapt against acute myeloid leukemia (AML) in newly diagnosed patients and three other indications.

Rydapt was also recommended as a treatment for adults with advanced systemic mastocytosis, a rare disease in which the body’s mast cells accumulate rapidly.

This latest CHMP opinion sets the stage for likely European Commission approval this year.

Rydapt, whose U.S. wholesale cost is nearly $7,500 for a two-week supply, was approved by the U.S. Food and Drug Administration in April.

Novartis is rebuilding its portfolio of cancer drugs after the expiration of patents on its blockbuster Gleevec in early 2016 exposed the $5 billion-a-year seller to generics from rivals including Sun Pharmaceuticals.

AML is a rare and aggressive cancer of the blood and bone marrow.

Other recent Novartis approvals or regulator recommendations have included Kisqali against a tough-to-treat form of breast cancer. The company is also aiming for the FDA’s blessing for its first-of-its-kind cell therapy CTL019 this year.

Novartis is banking on these cancer medications as well as heart failure drug Entresto, psoriasis treatment Cosentyx and its Sandoz unit’s growing portfolio of biosimilars to help return it to sales growth starting in 2018.

Reporting by John Miller and John Revill; editing by Jason Neely

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