Pfizer Expects to Launch First CCR5 Entry Inhibitor Maraviroc in July Following
FDA Testing of the Drug
Pfizer
will launch its antiretroviral drug maraviroc
(Celsentri) in July after FDA tests of the drug
conclude in the U.S., according
to Richard Paulson, head of Pfizer in South Africa, Japan Today reports.
According
to an unnamed Pfizer spokesperson, the drug, which will be taken orally, is scheduled
to be formally approved by FDA on June 20. An FDA panel of outside experts in
April unanimously has already recommended
that the agency approve maraviroc.
Pfizer has proposed using the drug
to treat people with advanced HIV disease or AIDS who have not responded to other
medications. Maraviroc works by blocking a protein, called CCR5, on human immune
system cells that HIV uses as a portal to enter and infect the cell.
Pfizer
plans to offer the drug along with a test developed by Monogram Sciences that
determines if people likely will respond to the treatment.
FDA in April
raised concerns that maraviroc could be associated with an increased risk of liver
damage, lymphoma, and infections. According to FDA, other CCR5 inhibitors under
development have been shown to increase safety risk issues. Pfizer said its studies
have shown that maraviroc has no significant effect on the heart and did not increase
the incidence of liver problems, cancer or infection compared
with other HIV/AIDS drugs.
Although FDA in April said it "continues
to be concerned about potential safety issues with the entire class of drugs,"
some agency reviewers said they noted no increases in lymphomas or infections
among people taking maraviroc. FDA reviewers have noted a "modest" increase
in liver problems among people taking the drug. Pfizer has proposed selling maraviroc
under the brand name Celsentri.
In
related news, Pfizer announced last week that it has applied for fast-track approval
of maraviroc from South Africa's
Medicines Control Council.
06/12/07
Source Kaiser Daily HIV/AIDS Report. Pfizer To Launch Antiretroviral Maraviroc
in July after FDA Tests Conclude, Official Says. June 8, 2007.
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