FDA Approves Tygacil for Community-Acquired Bacterial Pneumonia
FDA Approves New Indication for Wyeth's Tygacil (tigecycline) for the Treatment of Adult Patients with Community-Acquired Bacterial Pneumonia
COLLEGEVILLE, Pa., March 24, 2009 /PRNewswire-FirstCall/ -- Wyeth Pharmaceuticals, a division of Wyeth , announced today that the U.S. Food and Drug Administration (FDA) approved Tygacil (tigecycline), for the treatment of adult patients with community-acquired bacterial pneumonia (CABP) caused by susceptible strains of indicated pathogens. Tygacil was first approved by the FDA in 2005 for the treatment of complicated intra-abdominal infections (cIAI) and complicated skin and skin structure infections (cSSSI) caused by susceptible strains of indicated pathogens in adults.
"The approval of this new indication is timely. Antibiotic resistance continues to grow and new antimicrobials are needed," says Joseph Camardo, M.D., Senior Vice President, Global Medical Affairs, Wyeth Pharmaceuticals. "The approval of Tygacil for CABP is an important milestone in Wyeth's commitment to exploring new treatment options in the anti-infective therapeutic area."
Thomas File, M.D., Chief of Infectious Disease Services for Summa Health System in Akron, Ohio, says, "CABP is a serious and potentially fatal respiratory disease that affects millions of Americans each year. The approval of Tygacil for CABP means that physicians will have an additional option available to treat patients suffering from the disease."
CABP accounts for an estimated 4.5 million visits to physician offices, emergency departments, and outpatient clinics each year.
The approval was based on results of two randomized, double-blind, active-controlled, multinational studies (Studies 308 and 313) that evaluated Tygacil for the treatment of CABP in adults. The two studies (N=859) were conducted at 116 sites in 28 countries and evaluated the efficacy and safety of Tygacil compared with levofloxacin in subjects hospitalized with CABP. Results showed that clinical cure rates of patients hospitalized with CABP were comparable for both Tygacil and levofloxacin. Clinical cure rates in clinically evaluable patients were 90.6 percent for Tygacil and 87.2 percent for levofloxacin in Study 308 and 88.9 percent for Tygacil and 85.3 percent for levofloxacin in Study 313.
Community-acquired bacterial pneumonia, or CABP, is commonly defined as an acute infection of the pulmonary parenchyma (the functional part of the lungs) that is generally associated with at least some symptoms of acute infection, in a patient who has not been hospitalized or resided in a long-term care facility within 14 days of symptom onset. Symptoms of CABP include cough, fever, chills, fatigue, shortness of breath, and chest pain.
Tygacil is indicated for the treatment of adults with:
(cSSSI) caused by (vancomycin-susceptible isolates), (methicillin-susceptible and -resistant isolates), group (includes and , ,and
(cIAI) caused by (vancomycin-susceptible isolates), (methicillin-susceptible and -resistant isolates), group (includes and and
caused by (penicillin-susceptible isolates), including cases with concurrent bacteremia, (beta-lactamase negative isolates), and .
Tygacil, the first glycylcycline IV antibiotic has an expanded broad spectrum of in vitro activity against many gram positives, gram negatives, anaerobes, methicillin-resistant and -susceptible (MRSA and MSSA), and vancomycin-resistant enterococci (VRE). Tygacil is unaffected by extended-spectrum beta-lactamases (ESBLs).
With this approval, the in vitro profile of Tygacil has now been expanded to include: (ampicillin-resistant) and .
Tygacil can be used as an empiric monotherapy to treat a variety of cIAI and cSSSI, both hospital- and community-acquired, including complicated appendicitis, intra-abdominal abscesses, infected burns, deep soft-tissue infections, and infected ulcers.
Tygacil provides clinicians with an expanded broad-spectrum antibiotic option that can be used at the onset of treatment when the specific bacteria present are not yet known. When culture and susceptibility information are available, they should be considered in modifying antibacterial therapy. In addition, Tygacil does not require dosage adjustment in patients with impaired renal function, and is conveniently dosed every 12 hours.
For a copy of Tygacil Prescribing Information, please visit www.Wyeth.com.
Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women's health care, infectious disease, gastrointestinal health, central nervous system, inflammation, transplantation, hemophilia, oncology, vaccines and nutritional products.
Wyeth is one of the world's largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing and marketing of pharmaceuticals, vaccines, biotechnology products, nutritionals and non-prescription medicines that improve the quality of life for people worldwide. The Company's major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health.
CONTACT: Media, Gwen Fisher, +1-484-865-5160, or Douglas Petkus,+1-973-660-5218, both of Wyeth Pharmaceuticals, or Investors, JustinVictoria of Wyeth, +1-973-660-5340
Web site: http://www.Wyeth.com/
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Posted: March 2009
- Wyeth Receives Approvable Letter from FDA for Tygacil for the Treatment of Patients with Community-Acquired Pneumonia - May 29, 2008
- FDA Accepts Wyeth's Supplemental New Drug Application for Tygacil for the Treatment of Patients with Community-Acquired Pneumonia - October 24, 2007
- Wyeth to File for FDA Approval of Tygacil for the Treatment of Patients with Community-Acquired Pneumonia - July 6, 2007
- Tygacil Wyeth Pharmaceuticals - Treatment for Complicated Skin and Intra-abdominal Infections - June 15, 2005
- FDA Grants Tygacil (Tigecycline) NDA Priority Review Status - January 28, 2005
- Wyeth Seeks Global Regulatory Approval of Tygacil (Tigecycline) for Injection - December 15, 2004