Food and Drug Administration, U.S. Department of Health and Human Services - June 15, 1989
Brad Stone -- (301) 443-3285

Although many patients have already been receiving aerosolized pentamidine treatments through a special pre-approval distribution program, a large number of these patients have not been able to get medical insurance reimbursement for it. But today's approval, Dr. Sullivan said, will make the drug affordable to more patients since it is likely most private insurance providers will now pay for an approved drug.

"Today's approval will help many of those infected with the AIDS virus avoid one of the most deadly opportunistic infections associated with AIDS," said Secretary Sullivan. "It may help an estimated 100,000 or more individuals who are at risk of developing first or subsequent episodes of Pneumocystis carinii pneumonia and will, therefore, significantly improve the quality of their lives."

Dr. Sullivan noted that the cost of using aerosolized pentamidine to prevent Pneumocystis carinii pneumonia would probably represent only a fraction of the cost of treating patients who have developed this pneumonia, "but, most important, it should improve the quality of life for those at highest risk from this infection." The FDA, which approved the product, is a part of the U.S. Public Health Service and Dr. Sullivan's department.

Today's action coincides with the Public Health Service's publication of guidelines for prophylaxis against Pneumocystis carinii pneumonia in persons infected with the AIDS virus. The guidelines, which appear in the June 16, 1989 issue of the Centers for Disease Control's Morbidity and Mortality Weekly Report, are the recommendations from a panel composed of medical experts from the Public Health Service and leading medical centers. The use of aerosolized pentamidine to help prevent Pneumocystis carinii pneumonia is prominently recommended in the guidelines.

Aerosolized pentamidine will be labeled for use in patients who have had at least one episode of the pneumonia or who have greatly diminished immunity, as indicated by CD4 helper lymphocyte cell counts of 200 or less. CD4 helper cells are white blood cells that are critical components of the body's immune system and which are destroyed by the AIDS virus. Healthy individuals normally have CD4 helper cell counts of about 1,000 or more.

FDA Commissioner Frank E. Young, M.D., Ph.D., said his agency's approval was based largely upon clinical data from a community-based study conducted by the San Francisco Community Consortium. "The approval of this vital drug heralds a new era of close cooperation among FDA, industry and those community physicians who are on the front line of dealing with this terrible disease," Dr. Young said.

This is the first new drug approval emanating from a clinical trial sponsored jointly by a community research initiative and a pharmaceutical company. The trial, conducted by the San Francisco Community Consortium, a group of physicians with experience treating people infected with the AIDS virus, compared three dosages of the drug to determine which dose would be most effective. In this study, headed by Bruce Montgomery, M.D., David W. Feigel, M.D., M.P.H., and Gifford Leoung, M.D., individuals infected with the AIDS virus who were at high risk of developing the pneumonia had a lower incidence of infection when treated with this drug administered via the Respirgard II nebulizer at a 300 milligram dose every four weeks than similar patients treated with lower doses.

In November 1988, LyphoMed Inc. of Rosemont, Ill., which partially underwrote the San Francisco Community Consortium study, filed the new drug application that was approved today. Clinical data from this study continued to be collected through December 1988, and its final results were submitted to FDA in April 1989. In May 1989, FDA's Anti-Infective Drugs Advisory Committee unanimously recommended that FDA approve the drug. The company will market the approved drug under the trade name NebuPent.

The Respirgard II nebulizer, the filtered system specified in the drug's approved labeling, is manufactured by the Marquest Corp. of Engelwood, Colo. and is available through home health care retailers and hospital pharmacies.

Since February 1989, aerosolized pentamidine has been made widely available to patients under the agency's "treatment IND" regulations -- a plan for the use of an investigational new drug (IND) in selected patients facing serious or life-threatening conditions. Despite this status, many eligible patients were unable to receive reimbursement for the costs of this therapy from private or government health insurance providers. Although some companies have provided reimbursement, others were reluctant to pay until the drug was fully approved.

Injectable pentamidine, as distinct from aerosolized pentamidine, was approved in 1984 for the treatment of those already suffering from Pneumocystis carinii pneumonia.

Aerosolized pentamidine can provoke severe wheezing and coughing at the time of administration, as well as other adverse reactions. The long-term risks associated with its use are unknown.

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SOURCE: Food and Drug Administration (FDA).

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