Wyeth sees FDA accept Tygacil sNDA

Wyeth Pharmaceuticals has announced that its supplemental New Drug Application (sNDA) for Tygacil (tigecycline) has been accepted by the US Food and Drug Administration (FDA).

Tygacil, Wyeth’s first-in-class antibiotic, is indicated for the treatment of patients with community-acquired pneumonia (CAP).

The FDA will now approve or disapprove the sNDA or even request further data in support of the application.

Gary L Stiles, executive vice president at Wyeth, confirmed the seriousness of CAP in America.

“The acceptance of this sNDA is an important event as it brings Wyeth closer to providing physicians with a new option for the treatment of CAP.”

Two clinical studies informed the sNDA submission which saw 846 patients enrolled in the trials.

Data showed that Tygacil cured 89.7 per cent of patients who were hospitalised with CAP while levoflaxin, an existing treatment option for CAP, cured 86.3 per cent of studied patients.

Some common adverse events for Tygacil were recorded including nausea, vomiting and abdominal pain.

Earlier this month, Wyeth published its financial results for the third quarter of its 2007 fiscal year, with the company announcing a nine per cent increase in net revenues to $5.6 billion (2.74 billion pounds).