FDA Approves Tygacil, a Novel IV Antibiotic

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