APPROVES TYGACIL(TM), FIRST-IN-CLASS ANTIBIOTIC
, June 15/PRNewswire/ --
Provides Physicians With Treatment Alternative for Complicated Skin and
a novel I.V. antibiotic with a broad spectrum of antimicrobial
The U.S. Food and Drug Administration (FDA) today approved Tygacil(TM)
including activity against the drug-resistant bacteria
Staphylococcus aureus (MRSA). TYGACIL is indicated for
treatment of complicated intra-abdominal infections (cIAI) and
skin and skin structure infections (cSSSI) in adults. Approval of
first-in-class product comes at a time when the need for new antibiotic
to combat serious, resistant infections is increasing.
cSSSI, both hospital- and community-acquired, including complicated
TYGACIL can be used as an empiric monotherapy to treat a variety of cIAI
infected burns, intra-abdominal abscesses, deep soft tissue
and infected ulcers. TYGACIL provides clinicians with a novel,
option that can be used at the onset of treatment when the
bacteria present are not yet known. In addition, TYGACIL does not
dosage adjustment in patients with impaired renal function, and is
dosed every 12 hours.
A Clinical Challenge
infected with drug-resistant organisms are more likely to have longer
The U.S. Centers for Disease Control and Prevention (CDC) states that
stays and require treatment with multiple drugs. The increasing
of resistant bacteria often necessitates the use of combinations
antibiotics to fight infections. Antibiotic resistance costs
US$4 billion and US$5 billion annually. According to the CDC,
resistance has become so widespread that many significant
infections in the world are becoming resistant to commonly used
Antibiotic development has slowed to the point that FDA has had
Additionally, few broad-spectrum antibiotic agents are currently in
opportunities to approve new agents. In fact, development and approvals
new antibacterial agents have decreased by 56 percent over the past 20
(1998-2002 vs. 1983-1987). New classes of antibiotics are needed to
increasing antibiotic resistance among common pathogens.
was developed by Wyeth to overcome key mechanisms of
TYGACIL, the first antibiotic approved in a new class called
that have affected antibiotic use.
(cSSSI) caused by Escherichia coli, Enterococcus faecalis
TYGACIL is approved for adults with complicated skin and skin structure
isolates only), Staphylococcus aureus (
and -resistant isolates), Streptococcus agalactiae,
anginosus grp. (includes S. anginosus, S. intermedius, and S.
Streptococcus pyogenes, and Bacteroides fragilis.
(cIAI) caused by Citrobacter freundii, Enterobacter cloacae,
TYGACIL is also approved for adults with complicated intra-abdominal
coli, Klebsiella oxytoca, Klebsiella pneumoniae, Enterococcus
(vancomycin-susceptible isolates only), Staphylococcus aureus
isolates only), Streptococcus anginosus grp.
S. anginosus, S. intermedius, and S. constellatus), Bacteroides
Bacteroides thetaiotaomicron, Bacteroides uniformis, Bacteroides
Clostridium perfringens, and Peptostreptococcus micros.
phase III studies examining the safety and efficacy of TYGACIL for
The TYGACIL New Drug Application (NDA) submission included data from
treatment of cIAI and cSSSI. The submission also included in vitro data
activity against both gram-negative and gram-positive bacteria,
and certain drug-resistant pathogens.
cures rates in cSSSI to vancomycin and aztreonam, a combination
In clinical trials, empiric monotherapy with TYGACIL provided comparable
Empiric monotherapy with TYGACIL also provided clinical cure rates
to imipenem/cilastatin, an empiric treatment for cIAI. The overall
rate for TYGACIL (5.0 percent) was comparable to vancomycin
aztreonam (5.3 percent) and imipenem/cilastatin (4.4 percent).
around the world.
Wyeth now awaits decisions on approval of TYGACIL from other regulatory
Important Safety Information
TYGACIL should be administered with caution in patients with
TYGACIL is contraindicated in patients with known hypersensitivity to
hypersensitivity to, and may have adverse effects similar to,
class antibiotics. In clinical trials, the most common
adverse events in patients treated with TYGACIL were
(29.5 percent) and vomiting (19.7 percent).
and effectiveness of TYGACIL in patients below age 18 and lactating
TYGACIL may cause fetal harm when administered to a pregnant woman. The
have not been established. Use of TYGACIL during tooth development may
permanent discoloration of the teeth. Pseudomembranous colitis has been
with nearly all antibacterial agents and may range from mild to life
Monotherapy should be used with caution in patients with
apparent intestinal perforation.
For a copy of TYGACIL Prescribing Information, please visit