Please login to the form below

Not currently logged in
Email:
Password:

RSV drug rejected by FDA committee

AstraZeneca has said that a US Food and Drug Administration committee has not recommended the respiratory syncytial virus drug, motavizumab

AstraZeneca (AZ) has announced that a US Food and Drug Administration (FDA) committee has not recommended the respiratory syncytial virus (RSV) drug, motavizumab, for use in the US.

The Antiviral Drugs Advisory Committee voted 14 to 3 in favour of not giving the drug, which is used to prevent serious RSV in high-risk infants, the appropriate license for marketing. Motavizumab was developed by MedImmune, the worldwide biologics unit of AZ.

The committee had already announced concerns with the treatment, including potentially skewed respiratory admissions in local testing comparing the drug with the already approved palivizumab. The risk-benefit assessment of motavizumab was also an issue considering experiments showed it had three times as many non-fatal hypersensitivity adverse events as palivizumab.

The committee's decision is not final however, but will be considered by FDA reviewers in their licensing evaluation for motavizumab.

Despite the negative recommendation, Dr Genevieve Losonsky, vice president, Clinical Development, Infectious Disease at MedImmune, still had belief in the positive effects of the drug: "We continue to believe motavizumab offers a meaningful clinical benefit to patients at high risk for a very common and serious illness.

"We thank the committee for the thoroughness of its review today. We will work to address the issues raised by the committee and look forward to continuing to work with the FDA as it completes its review of our application."

Around 125,000 infants are hospitalised each year in the US as a result of RSV infections – the most common respiratory infection in infancy or childhood. Nearly all children have been infected at least once by the time they reach their second birthday.

Infants at high risk of the virus include children born prematurely, as well as those with chronic lung disease or congenital heart disease.

3rd June 2010

Share

COVID-19 Updates and Daily News

Featured jobs

PMHub

Add my company
Oncosec

OncoSec is a clinical-stage biotechnology company focused on developing cytokine-based intratumoral immunotherapies to stimulate the body's immune system to target...

Latest intelligence

Patient-centricity in improving patient recruitment advertising
This blog looks into the importance of concepts and patient centricity in patient recruitment....
AI and life sciences
AI: the smart money is on the smart thinking
Looking at the three key areas where AI is being applied: drug discovery, clinical decision-making and clinical trials...
Virtual Engagement At Porterhouse: Reflections on the past few months
A look at how the pitfalls of virtual engagement can be avoided and the key advantages of virtual client and KOL engagement strategies in a now predominantly digital world....

Infographics