AstraZeneca's (NYSE: AZN) attempt to come up with a successor to its blockbuster RSV drug Synagis has run into some heavy flak, with an FDA panel turning their thumbs down on motavizumab in a lopsided vote.
The experimental drug had been in MedImmune's pipeline as a successor to Synagis when AstraZeneca bought up the Maryland biotech three years ago. But by a vote of 14 to 3 the FDA experts raised a red flag on data linking motavizumab to a higher number of allergic reactions while criticizing the lack of proof of improved efficacy over Synagis--which loses patent protection in 2015. Synagis earns slightly more than a billion dollars a year. RSV is a respiratory illness that afflicts some 125,000 babies each year.
"We do not know what the true risk is and there's a signal that it could be significant," said panel member Michelle Roland, according to a Bloomberg report. "Are we comfortable advising you to take the chance of figuring it out in the real world or do we want to err on the side of caution?"
The rejection is a significant setback for AstraZeneca, which is badly in need of new drug approvals to make way for the looming loss of key patents. MedImmune, which AZ paid $15.6 billion for, was supposed to deliver one new biotech drug approval per year, but has failed to live up to expectations.
- see AstraZeneca's release
- read the story from Reuters
- here's the report from Bloomberg
ALSO: For the second year in a row AstraZeneca has won the EcoLeadership Award, decreasing energy use by 2 percent in 2009. Report