Show I I Panel P ane I 1 seeks new new I I AID AIDS drug g to market I Rui Jia-Rui Chong I Los Angeles Times I A federal advisory panel i Wednesday unanimously recommended accelerated approval for a new AIDS drug rug r I designed to treat the increasing i number of patients with drug drug- i i resistant strains of the virus I developed by Merck I i Co is IS the first in a class known i as inhibitors which I prevent the virus from merging into the DNA of human cells I IThe The panels panel's recommendation I follows the August approval of I Pfizer the first of ofa a class of drugs known as inhibitors The class was the first t I new one approved since 2003 I I think we have kind of come to another milestone in inthe inthe I Ithe the treatment of HIV said Dr Richard Haubrich a professor of medicine at atthe the University of f California San Diego referring to the relative bounty of new I drugs available to treat AIDS r i Jeff Bailey director of ff client I services for AIDS Project Los I Angeles added Any time a anew anew anew new option comes up for persons J I living with HIV that demonstrates I efficacy is relatively easy to I I Panel Continued on page 6 I I Panel to on AIDS AID S Continued from page 1 I tolerate with few side effects that's definitely cause for excitement Some members of the Food and Drug Administration advisory panel expressed concern over data showing a higher number of cancers and abnormal tissue growths in inpatients inpatients inpatients patients taking But Merck ta tives and FDA staff members said the rate of malignancies was comparable to that found in patients infected with a highly resistant drug-resistant virus Overall based on the data weve we've seen today the to risk-to-benefit ratio seems fairly favorable said Dr Marshall Glesby a panel member of the panel and director co-director of the Cornell University HIV Clinical Trials Unit Full approval of whose generic name is is expected within the next few months The FDA is not required to follow the recommendation of its advisory panel but usually does The malignancy issue focused on data from three clinical trials involving about patients with multi-drug multi resistance About subjects received and a cocktail of other AIDS drugs patients received a standard cocktail with a placebo In the group 13 patients developed malignancies such as cell carcinoma and lymphoma during the trial period which lasted from 16 to 24 weeks None of the patients taking a standard drug regimen plus placebo had any malignancies An FDA analysis of the studies said the difference between the two groups appeared to be a result of chance did not necessarily cause more malignancies rather the placebo group had an unusually low number according to the analysis Dr Robert a member of the advisory panel and chief of the HIV and AIDS Malignancy Branch at the National Cancer Institute said the difference in numbers appeared to be a sort of a random blip Several of the 11 II members of the advisory panel which met in Silver Spring Md recommended that Merck should do five years of up follow studies to confirm the drugs drug's safety The effectiveness of the drug was demonstrated in two studies involving about patients who ho had developed resistance to at least three existing classes of AIDS drugs A cocktail including suppressed the amount of virus in the blood to undetectable levels in about 62 percent of patients A placebo regimen suppressed the virus in about 34 percent according to the studies The number of patients resistant to three class of drugs has risen from about 16 percent in 2000 to 26 percent in 2006 in major urban clinics said Haubrich who has consulted for Merck and other phann pharmaceutical companies |