FDA Panel Backs Glaxo Wellcome's Ziagen For HIV/AIDS
Dow Jones Newswires
By Otesa Middleton
WASHINGTON (Dow Jones)--A federal panel gave its support to Glaxo
Wellcome Inc.'s fourth anti-AIDS drug, Ziagen.
The panel endorsed the treatment Monday for both adults and children in pill
and liquid form.
The final decision on the drug will come from the U.S. Food and Drug
Administration, which usually follows the advice of the outside expert panels it
convenes. Ziagen, which has been designated for an expedited, conditional
approval because it treats a life-threatening disease, will have to come back to
the agency once it has finished all of its trials to ask for full approval.
FDA asked its Antiviral Drugs Advisory Committee to review Ziagen because
the agency was concerned about cases of hypersensitivity to the drug, which
may result in death, said Dr. Heidi M. Jolson, director of the FDA's division
of antiviral drug products.
Jolson said the agency also wanted the committee to discuss Ziagen's
pediatric data and one of Glaxo's proposed drug combination regimens for the
drug.
Dr. Stephen LaFon, Glaxo's project leader for Ziagen, presented the panel
with the results of four Ziagen studies.
One study, of 173 adults who hadn't previously been treated with anti-AIDS
therapy, randomized patients to receive either Ziagen in combination with 3TC
and AZT or a placebo with 3TC and AZT.
Glaxo said the study found the Ziagen regimen was twice as effective in
reducing the amount of HIV levels.
In the next study, 205 children who previously had been treated were
randomly assigned to receive Ziagen with 3TC and AZT or a placebo with
3TC and AZT. The study showed Ziagen worked similarly in children as it did
in adults, said LaFon.
The pediatric study found that Ziagen performed better than 3TC and AZT
alone, LaFon said.
Also, Glaxo presented information on Ziagen in 99 adults with AIDS-related
dementia. LaFon said patients were given Ziagen or a placebo, both in
addition to their current treatment. Both groups of patients improved, so
Glaxo didn't apply to have the drug approved as a treatment for AIDS-related
dementia.
The fourth study involved 562 adults who hadn't been previously treated.
Patients were randomly assigned to receive Ziagen with 3TC and AZT or a
standard cocktail of Merck & Co.'s (MRK) protease inhibitor Crixivan, 3TC
and AZT.
LaFon said the preliminary results of the study just became available in
October and Glaxo hadn't yet revealed to investigators or patients which
patients were receiving which treatment.
The preliminary results showed that the treatment combinations were
producing virtually identical results in reducing HIV levels in patients and in
elevating counts of CD4 cells, the noninfected cells that help fight off the virus,
LaFon said.
Glaxo also conducted several other trials that showed Ziagen can be safely
administered in combination with other commonly used AIDS therapies,
LaFon said.
Dr. Seth Hetherinton, Glaxo's senior clinical research physician, said the most
common adverse reactions occuring in adult and pediatric patients taking
Ziagen were nausea, vomiting, diarrhea, fatigue and headache.
The company said the drug worked equally well regardless of gender or race. |
