Allergan receives FDA fast track status for apaziquone

Allergan has announced that the Food and Drug Administration (FDA) has granted fast track designation for the investigation of apaziquone (EOquin) for the management of non-muscle invasive bladder cancer.

In a statement, the company explained that around 70 per cent of all newly-diagnosed bladder cancer patients have the non-muscle invasive form of the condition.

Spectrum Pharmaceutical worked with Allergan on the trials that led to the FDA’s decision, which is designed to speed up the review of drugs that have the potential to deal with as-yet-unmet medical needs.

The company’s managing director, chairman, president and chief executive Rajesh Shrotriya said that the firm is pleased with the move.

“In a marker lesion study, where patients had previously failed multiple therapies, apaziquone produced a 67 per cent complete response and was well-tolerated,” he added, stating that further studies into the therapy will now take place.

Last month, Allergan announced that the FDA granted approval for ozurdex (dexamethasone intravitreal implant) as a treatment for central retinal vein occlusion or macular edema following branch retinal vein occlusion.