US-based pharmaceutical company Ariad Pharmaceuticals has filed a new drug application, requesting a priority review and accelerated approval of its chronic myeloid leukaemia treatment ponatinib.
Ariad previously received fast-track designation from the US Food and Drug Administration in 2010, enabling the company to use a rolling submission process for the drug.
Currently the application only covers patients who fail to respond to existing therapies, however Ariad aims to win approval to expand the administering of ponatinib to newly-diagnosed patients. The company hopes to win this approval by proving the drug to be more effective than the current standard of care in a late-stage clinical trial comparing ponatinib to Novartis’ Gleevec.
Ponatinib is a BCR-ABL inhibitor, an experimental class of cancer treatment that works by blocking genetic abnormalities causing chronic myeloid leukaemia. Patients are currently treated with medications such as Bristol-Myers Squibb‘s Spyrcel, or Novartis’ Tasigna or Gleevec. Combined, the three drugs generate annual sales of around $4.5bn.
Ponatinib has, however, been backed by some oncologists due to its performance in clinical trials which suggest it could prove to be more effective than its competitors, particularly in beating the cancer’s resistance to drugs.
Projections compiled by Ariad estimate that the drug could reap between $600m and $800m in sales from its initial target audience, with the majority of those sales coming from the US. This projection could rise to more than $1bn should ponatinib be proven to be more effective than Gleevec in the late-stage clinical trial.
Results from the study are not expected until 2014.