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FDA Urged to Consider New HIV Drug
NewsMax.com Wires Thursday, April 26, 2007
WASHINGTON -- The federal government should approve a novel drug that
targets the cells of HIV-infected patients and not the virus itself, health
advisers recommended Tuesday.
The 12 advisers unanimously voted to urge the Food and Drug Administration
to approve maraviroc, which Pfizer Inc. hopes to sell under the brand name
Celsentri. It would represent the first so-called CCR5 receptor antagonist
to be sold.
The drugs block a secondary but crucial doorway typically used by the human
immunodeficiency virus to enter white blood cells, which are important in
the immune system.
The FDA advisers recommended that Pfizer further study Celsentri's
interaction with other drugs and its effects on women and minorities. The
group's advice is nonbinding, but the FDA generally follows it.
The FDA and Pfizer have cited studies showing that adding Celsentri to a
traditional HIV treatment regimen was more effective in dropping the virus
below detectable levels. HIV is the virus that causes AIDS.
FDA concerns about the entire class of drugs include the possibility of
greater risk of infection, lymphoma or liver damage in HIV patients. The
drugs also have been linked to heart rhythm changes in laboratory animals.
FDA reviewers noted no increase in lymphomas or infections among patients
given Celsentri, but said there was a modest increase in liver problems.
Pfizer said its analyses of studies of the drug found no significant impact
on the heart, and no increased incidence of liver problems, cancer or
infection compared with treatment involving other HIV drugs.
Most worrisome is that the drugs could accelerate a shift from one variant
of HIV to another, a problem most often seen in the sickest AIDS patients.
Patients on Celsentri probably would have to be monitored to determine
whether the drug is driving such a shift.
Researchers have known for more than a decade that people who lack a working
version of the doorway targeted by the drug - the CCR5 receptor - are highly
resistant to infection by HIV or slow to develop AIDS once infected.
FDA Urged to Consider New HIV Drug
NewsMax.com Wires Thursday, April 26, 2007
WASHINGTON -- The federal government should approve a novel drug that
targets the cells of HIV-infected patients and not the virus itself, health
advisers recommended Tuesday.
The 12 advisers unanimously voted to urge the Food and Drug Administration
to approve maraviroc, which Pfizer Inc. hopes to sell under the brand name
Celsentri. It would represent the first so-called CCR5 receptor antagonist
to be sold.
The drugs block a secondary but crucial doorway typically used by the human
immunodeficiency virus to enter white blood cells, which are important in
the immune system.
The FDA advisers recommended that Pfizer further study Celsentri's
interaction with other drugs and its effects on women and minorities. The
group's advice is nonbinding, but the FDA generally follows it.
The FDA and Pfizer have cited studies showing that adding Celsentri to a
traditional HIV treatment regimen was more effective in dropping the virus
below detectable levels. HIV is the virus that causes AIDS.
FDA concerns about the entire class of drugs include the possibility of
greater risk of infection, lymphoma or liver damage in HIV patients. The
drugs also have been linked to heart rhythm changes in laboratory animals.
FDA reviewers noted no increase in lymphomas or infections among patients
given Celsentri, but said there was a modest increase in liver problems.
Pfizer said its analyses of studies of the drug found no significant impact
on the heart, and no increased incidence of liver problems, cancer or
infection compared with treatment involving other HIV drugs.
Most worrisome is that the drugs could accelerate a shift from one variant
of HIV to another, a problem most often seen in the sickest AIDS patients.
Patients on Celsentri probably would have to be monitored to determine
whether the drug is driving such a shift.
Researchers have known for more than a decade that people who lack a working
version of the doorway targeted by the drug - the CCR5 receptor - are highly
resistant to infection by HIV or slow to develop AIDS once infected.
