Potentially Life-Threatening Bloodstream Infection

[Guest guest]

Pfizer Receives FDA Approval For EraxisTM To Treat Candidemia, A

Potentially Life-Threatening Bloodstream Infection

http://www.medicalnewstoday.com/medicalnews.php?newsid=38421

Main Category: MRSA/Drug Resistance News

Article Date: 27 Feb 2006 - 3:00am (UK)

Pfizer Inc said today that EraxisTM (anidulafungin) has been

approved by the U.S. Food and Drug Administration to treat

candidemia, a potentially life-threatening bloodstream infection.

Candidemia is the most deadly of the common hospital-acquired

bloodstream infections, with a mortality rate of approximately 40

percent.

In the United States, candidemia affects approximately one in 5,000

people, resulting in an estimated 60,000 cases each

year. " Bloodstream infections such as candidemia can spread quickly

and are very dangerous, especially for patients with weakened immune

systems, " said Dr. ph Feczko, Pfizer's chief medical

officer. " Physicians treating these seriously ill patients now have

an important new treatment in Eraxis. "

Patients at high risk for candidemia and systemic candidiasis

(Candida infection that spreads throughout the body) include those

with compromised immune systems, stem-cell and organ-transplant

recipients, patients on chemotherapy, patients with catheters,

critically ill patients in intensive care units, surgical patients

and patients on prolonged antibiotic therapy. In the U.S., patients

with candidemia on average spend an additional 10 days in the

hospital at an average increase in hospital charges of about $39,000

per patient.

" In the clinical trial setting, patients taking Eraxis for the

treatment of candidemia had improved efficacy versus those taking

fluconazole, making Eraxis an important addition to the options in

antifungal treatment, " said Dr. Annette Reboli, head of the Division

of Infectious Diseases at University Hospital in Camden, New

Jersey, and lead clinical investigator. " In addition, Eraxis has

been shown to have a safety profile comparable to fluconazole and to

be compatible with many medicines commonly used by patients with

candidemia who have other serious health complications. "

Eraxis, an antifungal medicine of the echinocandin class, also was

approved by the FDA to treat two additional infections caused by the

Candida fungus-peritonitis and intra-abdominal abscesses - as well

as esophageal candidiasis, a fungal infection of the esophagus.

Eraxis builds upon Pfizer's extraordinary strength in medicines for

the treatment of infectious diseases, particularly antifungal

treatments. Pfizer's Diflucan® (fluconazole) has been the

longstanding gold standard treatment for candidemia and other fungal

infections, especially opportunistic infections in HIV/AIDS

patients. Pfizer's Vfend® (voriconazole), also a product of

innovative Pfizer research, is a treatment for serious mold and

yeast infections. Both Diflucan and Vfend are azole-type antifungal

treatments.

Eraxis is the only medicine that has demonstrated improved efficacy

versus fluconazole in a pivotal clinical trial for the treatment of

candidemia. Eraxis was added to the company's antifungal portfolio

through the acquisition of Vicuron in September 2005.

About Candida Infections

Candidemia is a systemic fungal infection that occurs when Candida

organisms are present in the blood. The bloodstream may then spread

Candida to organs and tissues throughout the body, causing systemic

candidiasis.

Systemic candidiasis is difficult to diagnose and can cause organ

failure, which may result in death. It can infect organs such as the

kidneys, liver, bones, muscles, joints, spleen, or eyes.

Esophageal candidiasis is a fungal infection of the esophagus that

is most common among people with compromised immune systems such as

people with HIV/AIDS.

About Eraxis

Eraxis is an antifungal agent indicated for the treatment of

candidemia and two other Candida infections, peritonitis (infection

of the abdominal cavity) and intra-abdominal abscesses. Eraxis has

not been studied in endocarditis, osteomyelitis, and meningitis due

to Candida, and has not been studied in sufficient numbers of

neutropenic patients (those with low white blood cell counts) to

determine efficacy in this group. It was also approved for

esophageal candidiasis, an infection of the esophagus caused by

Candida (relapse rates post-therapy were higher for patients on

Eraxis).

Important Safety Information

In clinical studies, Eraxis was as well tolerated as fluconazole and

the total number of drug-related adverse events was comparable to

fluconazole. The most common treatment-related adverse events for

Eraxis in the candidemia study included lower than normal levels of

potassium in the blood (3.1%), diarrhea (3.1%), and an increase in

ALT (a liver enzyme) (2.3%). In the esophageal candidiasis study,

the most common treatment-related adverse events for Eraxis were

headache (1.3%) and an increase of GGT (a liver enzyme) (1.3%).

Eraxis has not been associated with renal toxicity, and has no

clinically relevant drug-to-drug interactions. Eraxis also does not

require dose adjustments based on gender, race, age, HIV status,

hepatic insufficiency or renal insufficiency. (Safety and

effectiveness of Eraxis in pediatric patients has not been

established.)

Eraxis is not approved for use in patients with hypersensitivity to

anidulafungin, any component of Eraxis, or other echinocandin

agents. In some patients with serious underlying medical conditions

who were receiving multiple concomitant medications along with

Eraxis, clinically significant hepatic abnormalities have occurred.

Possible histamine-mediated symptoms have been reported infrequently

with Eraxis, including rash, urticaria, flushing, pruritis, dyspnea,

and hypotension.

Health care providers can get more information about Eraxis by

calling 1-800-438-1985. Information about Eraxis can also be found

at http://www.eraxisrx.com.

http://www.pfizer.com