Novartis leukaemia drug to get priority FDA review

Novartis is to receive a priority review from the Food and Drug Administration (FDA) for a new treatment designed for leukaemia patients.

The pharmaceuticals firm’s Tasigna drug will be granted an accelerated review time of six months, instead of the standard ten, after it was shown to offer efficacy benefits when compared to existing treatment options in clinical trials.

It is indicated as a treatment for patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukaemia (Ph+ CML) in chronic phase, with regulatory submissions having been filed in Europe, the US and Japan.

David Epstein, chief executive officer of Novartis’s pharmaceuticals division, said the performance of the drug in trials underlines its potential importance.

He said: “This priority review designation brings us one step closer to offering patients who are newly diagnosed with Ph+ CML in the chronic phase a promising new treatment option.”

Earlier this month, the healthcare firm announced that it has gained exclusive rights to develop Debio 025, a potentially promising new drug for the treatment of hepatitis C.