Pharmaprojects R&D Pipeline News Feed
Withdrawal of global marketing application for Pfizer’s cSSSI compound
9 Sep 2008
Pfizer is to globally withdraw all marketing applications for its glycopeptide antibiotic dalbavancin, following discussions with the regulatory agencies. It was awaiting approval in both the EU and the US for use in adults with complicated skin and skin structure infections (cSSSIs), including those caused by MRSA.
Whilst Pfizer is planning a global Phase III trial to generate additional data, two other glycopeptides for cSSSIs – oritavancin and telavancin – await a decision on regulatory approval. Lilly’s oritavancin, which was divested to Targanta Therapeutics from the previous licensee InterMune, has been given an action date of 8 December 2008 by the US FDA. Meanwhile, Californian concern Theravance and its worldwide partner Astellas are awaiting notice from the US authorities following the passing of the 21 July 2008 PDUFA date. An approvable letter citing GMP issues unrelated to telavancin was previously received.
In September 2005, Pfizer acquired the anti-infective focused company Vicuron Pharmaceuticals, gaining both anidulafungin and dalbavancin that were under review by the US FDA. Anidulafungin received US approval five months later and was launched in late 2006 as Eraxis for Candida fungal infections.
