| |
Benefits of Merck HIV Drug
Outweigh Risks, FDA Says
|
| |
| |
Wall St Jnl
By JENNIFER CORBETT DOOREN
August 31, 2007 10:45 a.m.
WASHINGTON -- The Food and Drug Administration said Friday that the benefits of a proposed HIV drug from Merck & Co. outweigh "the currently identified risks."
The FDA released its review of Isentress ahead of a panel meeting next Wednesday that is being called to make recommendations to the agency about whether the drug should be approved.
The agency said the potential risks of Isentress include liver injuries and cancer. The FDA said there were a higher number of cancers seen among patients in clinical studies receiving Isentress but said the "imbalance" appeared to reflect the low rate of cancers seen in the placebo group.
Isentress is designed to target one of three enzymes HIV needs to reproduce. Current drugs on the market attack the other two enzymes. If approved, Isentress would be the only drug to target the third enzyme, known as intergrase.
Patients with HIV typically are treated with a "cocktail" of two or three types of drugs. However, over time, most HIV viruses mutate and stop responding to the drugs, creating the need for new types of drugs.
The FDA panel of outside medical experts will be asked if data support "accelerated" approval of Isentress. Accelerated approval is a mechanism that calls for a six-month drug-review period rather than the typical 10-month review. Accelerated review is reserved for life-saving drugs.
The panel also will be asked whether treatment should be restricted to the types of patients enrolled in the clinical trials, or patients "with few or no remaining treatment options." The FDA usually follows its panel's advice but is not required to. The agency is expected to make a final decision on whether to approve Isentress in mid-October.
Earlier this year, Merck released data from two main clinical studies of the drug that involved about 700 patients. About 460 received Isentress on top of other HIV drugs, while about 240 received a placebo, or fake pill, along with other HIV drugs. The studies showed that after 16 weeks, slightly more than 60% of patients receiving Isentress had their HIV virus levels reduced to an undetectable level, compared with 33% to 36% of patients in the placebo group.
|
|
| |
| |
|
|
|
