Set back for nerve growth factor
Cadman, J.
Gmhc Treatment Issues the Gay Men's Health Crisis Newsletter of Experimental Aids Therapies 12(9): 12
1998
ISSN/ISBN: 1077-1824 PMID: 11365804 Document Number: 493925
The Food and Drug Administration (FDA) has suspended Genentech, Inc.'s plan to file a new drug application for nerve growth factor (NGF), a genetically engineered substance developed to combat HIV-related neuropathy. The FDA found that the results from ACTG 291 were insufficient to determine the safety and efficacy of NGF. No further studies are planned for using NGF as a treatment for neuropathy in HIV patients, however, patients currently participating in ACTG 291 can continue to receive NGF for 48 weeks through a trial extension. A new application for NGF may be filed for the treatment of diabetic-related neuropathy. If NGF is approved under this application, it may be prescribed off-label for HIV populations. HIV activists are concerned that Genentech is not proactive enough in developing NGF for HIV. Contact information is provided.