FDA News

FDA Approves of Pfizer's AIDS Drug Selzentry

(Aug 07, 2007)-- AIDS Healthcare Foundation (AHF) welcomed news that the FDA has approved Pfizer Inc.'s new AIDS salvage therapy, Selzentry (maraviroc), a different class of new antiretroviral AIDS drug which had been discussed and presented at the IAS conference. However, AHF urged both Pfizer and the pharmaceutical
industry as a whole to show some restraint as companies set prices for several new AIDS drugs that are expected to come to market over the next year. Pfizer announced that it plans to make this latest AIDS treatment available by September, and will market it at a wholesale price of $10,585 per patient per year (PPY)-or $29 per patient per day.

The world's largest drug maker also said that it would make the drug available through an expanded access program for patients with no insurance coverage or limited financial resources.

"We welcome the FDA approval of this clinically promising new drug into the arsenal of available AIDS treatments, particularly for use by patients who have developed resistance to many of the current antiretroviral
regimens available today," said Homayoon Khanlou, M.D., Chief of Medicine for AIDS Healthcare Foundation, the nation's largest and oldest and non-profit HIV/AIDS healthcare, research, prevention and education
provider, and which had participated in clinical research trials of the drug.

According to a news item in today's Kaiser Family Foundation 'Daily HIV/AIDS Report,' "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 has proposed using the drug to treat people with advanced HIV or AIDS who have not responded to other medications. Pfizer last month also announced that maraviroc can reduce HIV viral loads among people who have never taken antiretrovirals.

" However, AHF notes the drug will be among the first AIDS medicines to carry and FDA-required "black box warning" regarding potential liver toxicity; in addition, the drug will carry a warning about possible increased risk of heart attacks.

"In light of Ryan White funding cuts and the recent and severe shortage of funding for AIDS Drug Assistance Programs nationwide, we strongly urge Pfizer and the pharmaceutical industry as a whole to use restraint when pricing many of these new and promising AIDS drugs such as Pfizer's Selzentry," said Michael Weinstein, President of AIDS Healthcare Foundation. "While we are excited by the treatment possibilities this drug offers, we have serious concerns on the price of this drug, and we ask that it be priced fairly so that people in need of such lifesaving medicines may actually benefit from them."

In 2006, for the first time in the history of the AIDS epidemic, more than one million people in the U.S. were believed to be living with HIV or AIDS. As a result of antiretroviral treatment, many more people are living
longer with HIV/AIDS, and as a result, a greater burden has been put on the health care system, including several of the federally funded, state-run AIDS Drug Assistance Programs (ADAP) nationwide. State ADAPs are funded by the federal Ryan White CARE Act and are the primary source of HIV/AIDS medications for uninsured and underinsured Americans. In President Bush's 2007 budget, funding for AIDS care was largely flat-funded or saw only minor funding increases which were not proportional to the need based on and increasing national caseload.

"Given the enormous profit that pharmaceutical companies reap by selling medications to government programs-by far the largest purchasers of drugs in this country-it is incumbent that drug companies work to help ensure that AIDS patients who are not able to access medications due to state and federal funding gaps still have access to such lifesaving treatments. Pfizer is taking advantage of the hard work that advocates do
to make sure that funding is available for ADAP and Medicaid. Fair and equitable pricing of these drugs from the outset is one way to achieve this goal." added AHF's Weinstein.

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