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FDA Approves First Protease Inhibitors With Labeling for Use in Children

Date: March 14, 1997
Source: Food and Drug Administration (FDA)

The Food and Drug Administration today approved two HIV protease inhibitors -- some of the most powerful medicines against the infection -- for use in treating children.

Nelfinavir received its initial approval today -- including information on use in both adults and children -- approximately 3 months after its application was received. The labeling for nelfinavir includes a "pediatric use" statement, giving doctors specific dosage recommendations for patients 2 to 13 years old. In addition, ritonavir, a previously approved protease inhibitor, also received "pediatric use" labeling today.

Today's actions not only add another powerful weapon to our arsenal for treating HIV infection, but provide us with critical information on using these cutting edge drugs to help HIV positive children," said HHS Secretary Donna E. Shalala.

With each approval, we are providing more options in designing individualized treatment programs for adults and children," said Dr. Michael A. Friedman, FDA Lead Deputy Commissioner.

The "pediatric use" section in the drug labeling provides specific recommendations for the use of the drugs in children. A regulatory reform initiated in 1994 eased the process of including label information that helps physicians in treating pediatric patients -- particularly in serious or life-threatening situations. Now, such information can be provided when evidence suggests that the course of the disease and the effects of the drug are sufficiently similar in the pediatric and adult populations to permit extrapolation from adult efficacy data to pediatric patients.

Nelfinavir received accelerated approval, a regulatory mechanism under which FDA bases early marketing approval for a product on laboratory markers such as plasma HIV RNA (a measure of viral load) and CD4 cell counts until information about clinical endpoints such as disease progression or mortality is available.

FDA based its approval of nelfinavir on studies of up to 24 weeks in duration showing that the drug was active in combination with other antiretroviral drugs for the treatment of HIV or if administered alone. However, because the antiviral activity of nelfinavir is increased when used with other drugs approved for treatment of HIV, combination therapy is recommended.

The most frequent adverse event associated with the use of nelfinavir is diarrhea, which can usually be controlled with nonprescription drugs. Other adverse events reported during clinical trials included nausea, vomiting, and asthenia.

Nelfinavir should not be administered concurrently with terfenadine, astemizole, cisapride, trizolam or midazolam, because these drugs may inhibit its metabolism and create the potential for serious and/or life-threatening cardiac arrhythmias or prolonged sedation. FDA has worked with the manufacturer to ensure that these drug interactions with nelfinavir are clearly highlighted on the package label and that patient education materials are made available to health care professionals and patients.

Agouron Pharmaceuticals is marketing nelfinavir under the trade name Viracept. Ritonavir is marketed under the trade name Norvir by Abbott Laboratories.