Post by BelizeanBrownSugar on Mar 14, 2003 11:08:19 GMT -5
FDA Approves New AIDS Drug
Class Of Medication Blocks HIV From Cells
UPDATED: 9:46 a.m. EST March 14, 2003
WASHINGTON -- A dramatically different new AIDS drug, which could help patients with few other options, now has federal approval.
Fuzeon is the first in a new class of medications that help to block HIV from getting inside cells they would kill. Earlier drugs work after the virus has already invaded cells, by blocking substances that HIV uses to reproduce and spread.
The new class of drugs, which will be used along with other HIV medications, hasn't received marketing approval yet anywhere else in the world.
The Food and Drug Administration has given the drug accelerated approval. A researcher said Fuzeon could be especially valuable for patients who are showing resistance to the other treatments.
The scientist works for Quest Clinical Research in San Francisco. The New England Journal of Medicine released his study early because of the FDA drug approval.
"The accelerated approval of this new drug should provide new hope for those suffering from advanced HIV infection," Health and Human Services Secretary Tommy Thompson said. "While we work aggressively to prevent new HIV infections across the country, we also will continue to review potential new treatments so that drugs which are proven safe and effective are made available as quickly as possible to those Americans who could benefit from them."
Roche Pharmaceuticals of Nutley, N.J., has licensed the product from Trimeris Inc. of Durham, N.C., and will distribute Fuzeon.
According to the Centers for Disease Control and Prevention, there are an estimated 850,000 to 950,000 people currently living with HIV nationwide, with about 40,000 new HIV infections occurring in the United States every year.
A significant percentage of patients with chronic HIV have developed infection resistant to many of the existing medications, the CDC reports.
Class Of Medication Blocks HIV From Cells
UPDATED: 9:46 a.m. EST March 14, 2003
WASHINGTON -- A dramatically different new AIDS drug, which could help patients with few other options, now has federal approval.
Fuzeon is the first in a new class of medications that help to block HIV from getting inside cells they would kill. Earlier drugs work after the virus has already invaded cells, by blocking substances that HIV uses to reproduce and spread.
The new class of drugs, which will be used along with other HIV medications, hasn't received marketing approval yet anywhere else in the world.
The Food and Drug Administration has given the drug accelerated approval. A researcher said Fuzeon could be especially valuable for patients who are showing resistance to the other treatments.
The scientist works for Quest Clinical Research in San Francisco. The New England Journal of Medicine released his study early because of the FDA drug approval.
"The accelerated approval of this new drug should provide new hope for those suffering from advanced HIV infection," Health and Human Services Secretary Tommy Thompson said. "While we work aggressively to prevent new HIV infections across the country, we also will continue to review potential new treatments so that drugs which are proven safe and effective are made available as quickly as possible to those Americans who could benefit from them."
Roche Pharmaceuticals of Nutley, N.J., has licensed the product from Trimeris Inc. of Durham, N.C., and will distribute Fuzeon.
According to the Centers for Disease Control and Prevention, there are an estimated 850,000 to 950,000 people currently living with HIV nationwide, with about 40,000 new HIV infections occurring in the United States every year.
A significant percentage of patients with chronic HIV have developed infection resistant to many of the existing medications, the CDC reports.