Astellas announces withdrawal of MAA for skin tissue infection treatment

Astellas has announced the withdrawal of its European marketing authorisation application (MAA) for telavancin, a once-daily, injectable, bactericidal investigational antibiotic with a multifunctional mechanism of action for use in the treatment of complicated skin and soft tissue infections (cSSTI).

The company explains its European subsidiary submitted the telavancin MAA for adults suffering from cSSTI to the European Medicines Agency (EMEA) in April 2007.

It also notes it has withdrawn the MMA based on word from the EMEA’s Committee for Medicinal Products for Human Use, which said the data provided is not sufficient to allow the body to conclude a positive benefit/risk balance for the drug for the sole indication of cSSTI at the present time.

“Astellas currently intends to prepare a new MAA with expanded clinical trial data that was not available at the time of the initial application, including data from the hospital-acquired pneumonia phase III studies,” the company states.

Concluding, Astellas notes telavancin is also under review for marketing approval for cSSTI in the USA.

Earlier this month, the company announced the launch of Irribow – a serotonin 5-HT3 receptor antagonist – for the treatment of irritable bowel syndrome.