said Tuesday that it received government approval to begin marketing an antifungal drug to fight a rare but potentially dangerous blood infection.
The drug is Eraxis, which is designed to treat candidemia, a hospital-acquired infection that affects about 60,000 people a year in the U.S. and kills about 40% of them, Pfizer says.
"Bloodstream infections such as candidemia can spread quickly and are very dangerous, especially for patients with weakened immune systems," said Dr. Joseph Feczko, Pfizer's chief medical officer, in a prepared statement. Candidemia occurs when the Candida fungus enters the bloodstream, then may then spread to organs and tissues throughout the body.
Eraxis was one of two anti-infectives in late stage-development by
bought the company last year for $1.9 billion. Eraxis was known as anidulafungin during development.
The other drug, the
antibiotic dalbavancin , remains under review by the FDA. The agency may take action next week.
Eraxis and dalbavancin are viewed by Pfizer as successors to the antibiotic Zithromax and the antifungal Diflucan that are being hit by generic competition. Pfizer says clinical trials show that candidemia patients taking Eraxis had better results than those taking Diflucan, whose sales last year plummeted to $498 million, down 47% from 2004. Pfizer says the drugs' safety profiles are comparable.
The intravenously administered Eraxis also was approved by the FDA to treat other infections caused by the Candida fungus, peritonitis and intra-abdominal abscesses, as well as esophageal candidiasis, a fungal infection of the esophagus.
Patients at high risk for candidemia and systemic candidiasis, a Candida infection that spreads throughout the body, include organ-transplant recipients, people with compromised immune systems, those receiving chemotherapy and critically ill people in intensive care, Pfizer says.
Shares of Pfizer were off 11 cents to $25.71 in late afternoon trading.