A Look at the FDA's Briefing on Advanced Life Sciences' Restanza
Advanced Life Sciences Holdings, Inc.’s (ADLS) Restanza drug has shown a lot of promise in its clinical trials, but there are a few concerns brought up in the FDA’s briefing document.
Advanced Life Sciences Holdings, Inc. [[ADLS.OB]] shares surged more than 40 percent after it announced that the U.S. Food and Drug Administration (FDA) posted briefing documents on its web sites for the June 2, 2009 Anti-Infective Drug Advisory Committee (AIDAC) meeting to review and discuss the company’s New Drug Application for Restanza.
The briefing document provides the committee members with background information including clinical development, pharmacology-toxicology, microbiology, clinical pharmacology, efficacy, safety, and safety. However, the FDA is primarily concerned with two things when looking to approve drugs: they must be safe (safety) and effective (efficacy).
With regards to the drug’s safety, an FDA reviewer noted on page 27 of the document that:
“Per the applicant, none of the adverse events that led to death were considered related to the study drug. In contrast, per the FDA reviewer, there were 2 deaths in the Phase 3 studies (one in each treatment arm), and 1 death in the Phase 2 study (cethromycin arm) which were possibly related to study drug therapy … However, the numbers are small (the study is not powered to assess deaths as an endpoint), and preclude from making definitive conclusions.”
In reality, these deaths only amounted to 0.004% of the cethromycin treatment group and 0.007% of the clarithromycin treatment group. However, this is a potential disagreement between the company and the FDA that could lead to a hiccup in the approval process.
The FDA reviewer also made a note bout cardiac safety on page 45 of the document:
“The above discussion of cardiac safety is based on the applicant’s evaluation of their ECG studies. At the time this briefing document was prepared, the review of the QT interdisciplinary review team was pending. Preliminary findings raised questions about the applicant’s individual QT correction methodology, and suggested that there is a dose and exposure-dependent increase in QTcI with cethromycin. QTc effects of cethromycin will be included in the safety discussions at the upcoming advisory committee meeting.”
In the end, there seems to be little question about the drug’s efficacy, but there are a few concerns being raised about its safety. Whether or not the drug is approved will depend on the FDA’s interpretation of the death and cardiac safety concerns and any new information furnished by the company for their review. As a result, prudent investors may want to wait on the sidelines until the drug is approved, while speculators get onboard to ride the storm.
Source: FDA Briefing Document
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