Drugs@fda vitravene fomivirsen discontinued?

Was Vitravene (fomivirsen) discontinued, and when?

Vitravene (fomivirsen) was discontinued. Drugs@FDA shows Vitravene’s discontinuation status in its FDA review record and labeling history. The product’s discontinuation is tied to shifts in the standard of care for cytomegalovirus (CMV) retinitis and the availability of other treatments as the disease landscape changed. [1]

Why did FDA discontinue Vitravene (fomivirsen)?

Vitravene was an intravitreal antisense therapy designed for CMV retinitis in people with AIDS. As other CMV treatments became preferred and CMV retinitis management improved, the clinical need for Vitravene declined, which contributed to its discontinuation. [1]

What did Vitravene treat?

Vitravene (fomivirsen) was used to treat CMV retinitis. It was given by intravitreal injection. [1]

What happened to patients who were using it?

Once discontinued, no new treatment courses would be started through normal supply channels. Patients who had been receiving it would have been managed with alternative therapies for CMV retinitis based on clinician judgment and available treatment options. (Discontinuation guidance is reflected in Drugs@FDA’s record of the product’s market status.) [1]

Where to confirm in Drugs@FDA?

On Drugs@FDA, the discontinuation information is captured under the product’s entry and related labeling/approval history, including status notes that reflect that Vitravene is no longer marketed. [1]

Sources

1. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=050400