Durata Therapeutics, Inc. (DRTX) continues to progress with its lead candidate, dalbavancin, which is being developed for the treatment of patients with complicated skin and soft tissue infections (cSSTI).
Earlier this month, Durata submitted its Marketing Authorization Application (MAA) to the European Medicines Agency (:EMA) for dalbavancin seeking approval for the marketing and sale of dalbavancin for the treatment of patients with cSSTI.
Durata recently announced that its MAA has been accepted for review by the EMA. Durata expects a decision by the first half of 2015.
The MAA was submitted based on positive results from three phase III trials – DISCOVER 1, DISCOVER 2 and VER001-9.
The data from DISCOVER 1 and DISCOVER 2 indicated that dalbavancin achieved its primary efficacy endpoint of non-inferiority of clinical response at 48 to 72 hours after initiation of therapy. Dalbavacin also achieved its secondary endpoint, which was clinical success at the end of treatment.
We remind investors that the U.S. Food and Drug Administration (:FDA) accepted Durata’s New Drug Application (:NDA) for Dalvance (dalbavancin) for priority review in Nov 2013.
Durata is seeking FDA approval of Dalvance for the treatment of patients with acute bacterial skin and skin structure infections (:ABSSSI) caused by susceptible gram-positive microorganisms, including MRSA (methicillin resistant Staphylococcus aureus). A decision by the FDA is expected by May 26, 2014.
Durata currently does not have any marketed product in its portfolio. Hence, the successful development and commercialization of dalbavancin will be a big boost to the company’s portfolio.