MADISON, N.J. -- The Food and Drug Administration (FDA) today approved Tygacil (tigecycline), a novel IV antibiotic with a broad spectrum of antimicrobial activity, including activity against the drug-resistant bacteria methicillin-resistant Staphylococcus
aureus (MRSA). Tygacil is indicated for the treatment of complicated intra-abdominal infections (cIAI) and complicated skin and skin structure infections (cSSSI) in adults. Approval of this first-in-class product comes at a time when the need for new antibiotic options to combat serious, resistant infections is increasing.
"Life-threatening infections are a growing concern globally," says Dr.
Joseph Camardo, senior vice president of global medical affairs for Wyeth
Pharmaceuticals. "Bacterial infections are becoming more difficult to treat,
with resistant strains on the increase. The approval of Tygacil will provide
physicians with an important option for patients with complicated skin, skin
structure, and intra-abdominal infections."
Tygacil can be used as an empiric monotherapy to treat a variety of cIAI
and cSSSI, both hospital- and community-acquired, including complicated
appendicitis, infected burns, intra-abdominal abscesses, deep soft tissue
infections, and infected ulcers. Tygacil provides clinicians with a novel,
broad-spectrum option that can be used at the onset of treatment when the
specific bacteria present are not yet known. In addition, Tygacil does not
require dosage adjustment in patients with impaired renal function, and is
conveniently dosed every 12 hours.
The Centers for Disease Control and Prevention (CDC) states that
persons infected with drug-resistant organisms are more likely to have longer
hospital stays and require treatment with multiple drugs. The increasing
prevalence of resistant bacteria often necessitates the use of combinations of
antibiotics to fight infections. Antibiotic resistance costs U.S. society
between $4 billion and $5 billion annually. According to the CDC, antibiotic
resistance has become so widespread that many significant bacterial infections
in the world are becoming resistant to commonly used antibiotics.
Additionally, few broad-spectrum antibiotic agents are currently in
development. Antibiotic development has slowed to the point that FDA has had
few opportunities to approve new agents. In fact, development and approvals
of new antibacterial agents have decreased by 56 percent over the past 20
years (1998-2002 vs. 1983-1987). New classes of antibiotics are needed to
address increasing antibiotic resistance among common pathogens.
Source: Wyeth Pharmaceuticals