Cubist files MAA for TR 701 at EMA for Infections - Cubist Pharma
The European Medicines Agency has accepted for review the Marketing Authorization Application for the antibiotic TR 701 (tedizolid phosphate), from Cubist Pharma. Cubist is seeking approval of tedizolid for the treatment of complicated Skin and Soft Tissue Infections (cSSTI), with a decision from the European Commission (EC) expected during the first half of 2015.
The MAA submission is based on positive data from two global Phase III clinical studies of tedizolid, which met the primary and secondary endpoints defined by the EMA and FDA. Cubist expects to submit a New Drug Submission (NDS) to Health Canada during the first half of 2014 in acute bacterial skin and skin structure infections (ABSSSI).
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
4 mins