Regulatory agencies say that they require more data, prompting the company to schedule another Phase III trial.
Pfizer is withdrawing all marketing applications related to dalbavancin for the treatment of complicated skin and skin structure infections (SSSIs) in adults. The company says that it is following feedback from regulatory authorities and will conduct another Phase III trial to support future regulatory submissions.
Pfizer had previously filed an NDA as well as an MAA based on a Phase III trial that showed that two doses of dalbavancin were as well tolerated and as effective as linezolid given twice-daily for 14 days for the treatment of patients with complicated SSSI including those infected with MRSA. Pfizer markets linezolid under the name Zyvox.
The company was not available to comment on what additional information regulatory authorities requested and how the planned Phase III study will address these concerns.
Pfizer has a slew of late-stage failures. In April, the company cancelled its melanoma study of tremelimumab. In the last couple of years, Pfizer has also had to pull Exubera from the market and ax development of another cholesterol drug.
Besides conducting another global multicenter study, Pfizer says that a pediatric program with dalbavancin is also planned.
Dalbavancin is a member of the glycopeptide class of antibiotics. Pfizer acquired the compound in September 2005 through its purchase of Vicuron Pharmaceuticals.
