FDA advisory committee shoots down Vivus’ Qnexa
MOUNTAIN VIEW, Calif. The possibility of a new drug for treating obesity suffered a setback Thursday as a Food and Drug Administration advisory committee voted against recommending its approval.
The FDA Endocrinologic and Metabolic Drugs Advisory Committee voted 10 to 6 against recommending approval for Vivus’ drug Qnexa (phentermine and topiramate), citing safety concerns such as the possibility of psychiatric problems and birth defects.
“We appreciate the advisory committee’s recognition of obesity as a significant health crisis and the challenges associated with the treatment of this disease,” Vivus CEO Leland Wilson said. “We are disappointed with the advisory committee’s vote.”
The company said it would attempt to address the committee’s concerns. An advisory committee vote is a recommendation, and while the FDA will take it into account when deciding whether to approve a drug, it is not bound to follow it.
‘Preschool is Cool: Counting with Elmo’ arrives on DVD this fall
BURBANK, Calif. Warner Home Video is bringing Sesame Street’s beloved resident, Elmo, to DVD.
“Preschool is Cool: Counting with Elmo” supports such early math skills as number recognition, counting and enumeration with the help of Elmo and his friends.
“Warner Home Video is very happy to introduce ‘Counting with Elmo, ‘our newest DVD title in Sesame Street’s new DVD set ‘Preschool is Cool,’” said Amit Desai, WHV VP family animation and partner brands marketing. “Counting is an essential tool that every preschooler must learn and there’s nobody better than the beloved Elmo and Professor Grover to show kids how fun and exciting numbers can be.”
“Preschool is Cool: Counting with Elmo” is available on DVD Sept. 14, for a suggested retail priceof $14.98.
Keryx gets orphan-drug designation for neuroblastoma treatment
NEW YORK The Food and Drug Administration has given special designation to an investigational treatment for a cancer of the nervous system that affects children.
Keryx Biopharmaceuticals announced Wednesday that it received orphan drug designation for KRX-0401 (perifosine), a treatment for neuroblastoma. No FDA-approved treatments exist for the disease.
The FDA gives orphan drug designation to investigational treatments for rare illnesses or those affecting fewer than 200,000 patients in the United States. The designation entitles the drug maker to seven years’ market exclusivity following approval, tax benefits and exemption from certain application filing fees.