October 15, 2014
By Riley McDermid, BioSpace.com Breaking News Sr. Editor
Biopharma giant AstraZeneca is holding its breath over regulatory approval from the European Medicines Agency later this month for its ovarian cancer drug olaparib, Reuters reported Wednesday.
The company has told investors it could see sales of as much of $2 billion annually if the cell therapy drug wins approval for a larger rollout. Thus far it has seen promising results in clinical trials but was denied accelerated approval by American regulators earlier this year.
The company said a decision from the EMA is expected on either Oct. 23 or 24.
AstraZeneca’s cancer drug pipeline includes multiple drug candidates but is currently focused on the future of olaparib.
The drug has shown promise in treating patients with hereditary gene mutations, and if it can be shown to be successful in cell repair processes, could eventually be used for both gastric and breast cancers.
The British drugmaker has projected cancer group sales could skyrocket as much as 75 percent by 2023--but those numbers rest not only clinical trial successes, but the increasingly difficult navigation of global regulatory bodies.
