FDA:Advanced Life's Restanza Has No Unexpected Side Effects
29 Maggio 2009 - 5:08PM
Dow Jones News
Studies involving Advanced Life Sciences Holdings Inc.'s (ADLS)
pneumonia drug revealed no unexpected safety concerns, Food and
Drug Administration scientists said Friday.
Chicago-based Advanced Life Sciences is seeking FDA approval for
a new antibiotic to treat mild to moderate types of pneumonia.
Clinical studies involving the drug, Restanza, revealed safety
concerns that are common with other types of pneumonia and
bacterial antibiotics, including diarrhea, nausea and headaches,
FDA scientists said in briefing documents posted to the agency's
Web site Friday.
An FDA-sponsored panel of medical experts will discuss Restanza
Tuesday, and may recommend whether to approve the drug. If
approved, Restanza would treat patients over the age of 18 who
suffer from community-acquired pneumonia. Roughly 1 million people
over the age of 65 suffer from the infection annually, with
symptoms that include fever and hypothermia. The FDA says the
infection can often result in death.
Studies of Restanza reveal a mixed picture of effectiveness when
compared to current antibiotics. Several studies showed Restanza
was slightly better than current antibiotics, such as
clarithromycin. Other studies showed current treatments were more
effective than Restanza.
Advanced Life Sciences said the medical community needs
Restanza, as bacterial infections essentially mutate and render
current treatments relatively ineffective. The company said
Restanza's benefits outweigh its risks, "something which has become
increasingly difficult for an antibacterial agent to achieve in the
recent past."
Advanced Life Sciences acquired the antibiotic in 2005 from
Abbott Laboratories (ABT). Abbott studied the antibiotic from 1999
to 2002 but stopped developing it. The FDA said Abbott's studies
don't provide much evidence for Restanza's effectiveness, but do
contribute to the product's safety profile.
-By Jared A. Favole, Dow Jones Newswires; 202.862.9207;
jared.favole@dowjones.com