Novartis withdraws application for mastocytosis treatment

Novartis has announced that it has withdrawn its application for European marketing authorisation for Glivec.

The pharmaceutical manufacturer states that the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use provided insufficient data to determine a positive balance of benefits in relation to risk for the use of Glivec in aggressive systemic mastocytosis.

Novartis has consequently formally notified the EMA that it will no longer apply for marketing authorisation for Glivec in 50 mg and 100 mg capsules and 100 mg and 400 mg film-coated tablets.

Mastocytosis is a disease where mast cells accumulate in organs such as the spleen and in bone marrow. It can lead to organ failure with a poor long-term outcome. Glivac was designed as a treatment for the disease in August 2005.

The drug was first authorised in 2001 and is currently used for the treatment of patients with leukaemia, Kit, gastrointestinal stromal tumours and patients with dermatofibrosarcoma protuberans.

Meanwhile, Novartis recently announced that its drug for hepatitis B has gained a “major milestone”.

Tyzeka, a once-a-day oral treatment for the hepatitis B virus, is a “promising treatment option” for patients, especially given the fact that it has bee approved six years after entering clinical development, according to the pharmaceutical manufacturer.

The drug has been submitted for European approval, an event described James Shanon at Novartis Pharma AG as “a significant step” in increasing the availability of the treatment.