Wyeth was celebrating after the US Food and Drug Administration granted priority review status to the company’s new antibiotic, Tygacil (tigecycline).
Tygacil is the first in a new class of antibiotics, and Wyeth is specifically seeking to win the green light for Tygacil as a single agent therapy to treat patients with complicated intra-abdominal infections and complicated skin and skin structure infections.
Tygacil is one of 11 products that Wyeth plans to submit with the regulatory authorities in the three years to 2007 that are expected to “significantly contribute” to its financial performance, which has suffered at the hands of the diet-drug litigation [[03/06/04c]]. It has also been filed with the regulatory authorities in Europe, Australia and Switzerland. The firm notes that, in the US, hospital-acquired infections alone afflict approximately 2 million patients and kill nearly 90,000 people annually – around 70% of these infections are resistant to at least one drug. Antibiotic resistance leads to increased mortality and morbidity and costs US society at least $4 billion dollars each year.