FDA Approves Foscarnet for HIV-Related CMV Retinitis, Herpes

Emma Hitt, PhD

Disclosures

May 10, 2012

May 10, 2012 — The US Food and Drug Administration (FDA) has approved foscarnet sodium injection (Foscavir, Clinigen) for the treatment of HIV/AIDS-related cytomegalovirus (CMV) infections and herpes.

Foscarnet sodium is now indicated for the treatment of CMV retinitis in patients with HIV and acyclovir-resistant mucocutaneous herpes simplex virus infections in immune-compromised patients in the United States, in addition to its availability in several countries in the European Union as well as Australia, Singapore, and Mexico. Foscarnet sodium is also indicated for the treatment of CMV in hematopoietic stem cell transplant patients in Japan.

The British company Clinigen acquired global rights to the drug from AstraZeneca in March 2010. Hospira was given the right to distribute foscarnet to US patients on an emergency supply basis beginning in September 2011. Now that US FDA approval has been received, Hospira has the exclusive rights to market, promote, and distribute the drug in the United States.

Foscarnet sodium injection is an organic analog of inorganic pyrophosphate that inhibits replication of herpes viruses in vitro, including CMV and herpes simplex virus types 1 and 2.

Foscarnet sodium has a boxed warning regarding kidney toxicity. Frequent monitoring of serum creatinine, with dose adjustment for changes in renal function, and adequate hydration is imperative.

In controlled studies, anemia has been reported in 33% of patients receiving foscarnet sodium. Granulocytopenia has been reported in 17% of patients, with 1% (2/189) being terminated from these studies because of neutropenia.

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