FDA Advisory Committee votes against approving MedImmune/AstraZeneca's motavizumab for RSV

Probably coming as no surprise, the US Food and Drug Administration's Antiviral Drugs Advisory Committee yesterday voted 14 to three to recommend that motavizumab should not be licensed for marketing regarding the prevention of serious respiratory syncytial virus (RSV) disease in high-risk infants.

The drug filing was made in 2008 by Anglo-Swedish drug major AstraZeneca's US biologics subsidiary MedImmune (which it acquired in 2007 for $15 billion), and has been subject to previous delays and requests for additional information. Also, the advisory opinion comes after the FDA this week posted somewhat negative briefing documents on its web site, questioning the risk/benefits of motavizumab, citing in particular allergy reactions compares with the drugmaker's older RSV agent Synagis (palivizumab (The Pharma Letter June 1). It had been hoped that the new product would replace Synagis before it loses patent protection in 2015.

'We continue to believe motavizumab offers a meaningful clinical benefit to patients at high risk for a very common and serious illness,' said Genevieve Losonsky, vice president, clinical development, infectious disease, at MedImmune, adding that the company '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.'