TopoTarget's Savene cleared by EC

The European Commission has granted Danish drugmaker TopoTarget marketing approval for its first product, Savene (dexrazoxane), a drug that protects a patient's tissue from accidental exposure to anthracycline anticancer drugs administered during chemotherapy.

TopoTargets noted that the US Food and Drug Administration has reviewed its New Drug Application for Totect (the drug's US brand name) and has issued an approvable letter, further details of which were not disclosed.

The European approval means that TopoTarget still expects to launch Savene by the end of the year, noting that this represents a seven-year development time-frame from conception to launch.