COMUNICADO: More Clinical Data Required to Support European Approval of CAP Indication for TYGACIL (1)

Publicado 24/04/2008 0:07:39CET

COLLEGEVILLE, Pennsylvania, April 23 /PRNewswire/ --

-- Wyeth Withdraws European Application

Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), announced today that it is withdrawing its application for an extension to the European Marketing Authorization for TYGACIL(R) (tigecycline). This extension sought approval of TYGACIL for the treatment of community-acquired pneumonia (CAP). Wyeth's action is based on its understanding of the Committee for Medicinal Products for Human Use (CHMP) assessment that the TYGACIL CAP pivotal clinical trials did not include a sufficient number of severely ill CAP patients to alleviate reviewer concerns regarding efficacy in this subpopulation. TYGACIL is currently approved in Europe for the treatment of complicated intra-abdominal infections and complicated skin and soft tissue infections in adults.

"We are disappointed that we were not able to allay the concerns of the CHMP, and are evaluating the appropriate next steps to take in Europe," says Gary L. Stiles, M.D., Executive Vice President and Chief Medical Officer, Wyeth Pharmaceuticals. "In October 2007, the U.S. Food and Drug Administration (FDA) accepted the filing of our supplemental New Drug Application for TYGACIL for the treatment of patients with CAP. We believe that the clinical trial data submitted to the FDA, as well as other regulatory authorities around the world, demonstrate the safety and efficacy of TYGACIL for the proposed CAP indication."

The FDA is currently reviewing this application and a decision is expected during the second quarter of 2008. TYGACIL has been approved for use in patients with CAP in the Philippines and Thailand. Regulatory applications are also pending in Australia, Brazil, Canada, Switzerland and India.

TYGACIL(R) (tigecycline) is indicated for the treatment of adults with:
-- Complicated skin and skin structure infections caused by Escherichia
coli, Enterococcus faecalis (vancomycin-susceptible isolates only),
Staphylococcus aureus (methicillin-susceptible and -resistant
isolates), Streptococcus agalactiae, Streptococcus anginosus group
(includes S. anginosus, S. intermedius, and S. constellatus),
Streptococcus pyogenes, and Bacteroides fragilis
-- Complicated intra-abdominal infections caused by Citrobacter freundii,
Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella
pneumoniae, Enterococcus faecalis (vancomycin-susceptible isolates
only), Staphylococcus aureus (methicillin-susceptible isolates only),
Streptococcus anginosus group (includes S. anginosus, S. intermedius,
and S. constellatus), Bacteroides fragilis, Bacteroides
thetaiotaomicron, Bacteroides uniformis, Bacteroides vulgatus,
Clostridium perfringens, and Peptostreptococcus micros

Important Safety Information
-- To reduce the development of drug-resistant bacteria and maintain the
effectiveness of TYGACIL and other antibacterial drugs, TYGACIL should
be used only to treat infections proven or strongly suspected to be
caused by susceptible bacteria
-- Anaphylaxis/anaphylactoid reactions have been reported with nearly all
antibacterial agents, including tigecycline, and may be life-
-- TYGACIL is contraindicated in patients with known hypersensitivity to
-- TYGACIL should be administered with caution in patients with known
hypersensitivity to tetracycline class antibiotics
-- Glycylcycline class antibiotics are structurally similar to
tetracycline class antibiotics and may have similar adverse effects.
Such effects may include: photosensitivity, pseudotumor cerebri, and
anti-anabolic action (which has led to increased BUN, azotemia,
acidosis, and hyperphosphatemia). As with tetracyclines, pancreatitis
has been reported with the use of TYGACIL
-- The safety and efficacy of TYGACIL in patients with hospital-acquired
pneumonia have not been established
-- In clinical trials, the most common treatment-emergent adverse events
in patients treated with TYGACIL were nausea (29.5%) and vomiting
-- TYGACIL may cause fetal harm when administered to a pregnant woman
-- The safety and effectiveness of TYGACIL in patients below age 18 and
lactating women have not been established
-- Clostridium difficile-associated diarrhea (CDAD) has been reported with
use of nearly all antibacterial agents, including TYGACIL, and may
range in severity from mild diarrhea to fatal colitis
-- Concurrent use of antibacterial drugs with oral contraceptives may
render oral contraceptives less effective
-- The use of TYGACIL during tooth development may cause permanent
discoloration of the teeth. TYGACIL should not be used during tooth
development unless other drugs are not likely to be effective or are
-- Prothrombin time or other suitable anticoagulant test should be
monitored if TYGACIL is administered with warfarin
-- Monotherapy should be used with caution in patients with clinically
apparent intestinal perforation
-- In patients with severe hepatic impairment (Child Pugh C), the initial
dose of TYGACIL should be 100 mg followed by 25 mg every 12 hours.
Patients should be treated with caution and monitored for treatment
-- The following drugs should not be administered simultaneously through
the same Y-site as TYGACIL: amphotericin B and diazepam

Please see Prescribing Information.

Wyeth Pharmaceuticals:

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.