Data Sought on Motavizumab Hypersensitivity

If studies showed it was 10% more effective than palivizumab in reducing hospitalizations, then the risks of non–life-threatening skin reactions and rare cases of more severe anaphylaxis “might be acceptable risks in this high-risk population who comes in and not infrequently expires from RSV,” he added.

Since approval, an estimated 1.2 million people have received palivizumab and 10 cases of anaphylaxis have been reported to the FDA's voluntary adverse event reporting program, according to the FDA.

A warning about the potential for anaphylaxis is on the palivizumab label.

If motavizumab is approved, MedImmune plans to market the drug as Rezield, with a risk management plan that would include educating prescribers about how to manage skin reactions.

The plan also would involve enhanced vigilance of adverse events. Postmarketing studies would address issues that include evaluating the rates and severity of hypersensitivity reactions associated with motavizumab, the emergence of motavizumab-resistant RSV, and adverse event rates in the real-world setting.