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CDC Group on RSV immunoprophylaxis still working.

ATLANTA -- In the wake of a Food and Drug Administration advisory panel vote against recommending licensure of a new drug for the prevention of respiratory syncytial virus, a Centers for Disease Control and Prevention working group on RSV immunoprophylaxis will continue to develop recommendations for the use of currently available products, the group's chair said.

The new drug currently under FDA review is motavizumab (MedImmune/AstraZeneca), a humanized monoclonal antibody. The FDA advisory panel expressed concern that the drug has additional safety issues but no clear benefit over existing products on the market, Dr. Lance Chilton reported at the meeting. Efforts will continue to develop recommendations for prophylaxis, based on available information on disease burden, safety, efficacy, and economics, said Dr. Chilton, chair of the RSV immunoprophylaxis working group and a pediatrician with the Young Children's Health Center at the University of New Mexico, Albuquerque.

RSV is the leading cause of lower respiratory tract illness in infants and young children, and currently there is no vaccine available, Dr. Chilton said, noting that efforts to develop a vaccine are ongoing, and "when it comes, it will change the face of pediatrics."

Until then, preventive treatment is available in the form of palivizumab--a safe and effective product for immunoprophylaxis, according to Dr. Chilton. However, the drug is expensive with an estimated cost of nearly $6,700 per patient per year, and guidelines for appropriate use are needed, he said.

Dr. Chilton said the working group's efforts to develop such guidelines will include:

* A review of the epidemiology of RSV infection, including seasonality and host and environmental risk factors for severe disease.

* A review of the safety and efficacy of prophylaxis.

* An assessment of the costs and benefits of prophylaxis.

* Identification of the areas requiring further research for informing recommendations.

* Drafting of recommendations for ACIP consideration.

Up to 125,000 hospitalizations for RSV occur in the United States each year, with the highest incidence in young infants, and with a disproportionate burden among those with lung disease, heart disease, and prematurity. The FDA is currently scheduled to review the biologics licensing application for motavizumab in August.

Disclosures: Dr. Chilton reported no conflicts of interest.



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Author:Worcester, Sharon
Publication:Pediatric News
Date:Sep 1, 2010
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