FDA committee votes to recommend changes to flu drug labels
WASHINGTON The Food and Drug Administration’s Pediatric Advisory Committee voted 9 to 5 to recommend changing the labels of Roche and GlaxoSmithKline’s flu medications Tamiflu and Relenza, respectively, to reflect the risk for neuropsychiatric adverse events.
The committee did not say what changes specifically should be made or whether the labels should be the same for both drugs. The FDA also said that the precise relationship between Tamiflu and neuropsychiatric adverse events, including suicides, couldn not be determined. The committee did, though, propose to include an indication that the adverse events are sometimes fatal and to add language showing the uncertainty over Tamiflu’s causal effect.
The meeting was the committee’s third after convening in 2005 to discuss reports of neuropsychiatric adverse events in pediatric patients in Japan who received Tamiflu. Last year, Roche revised its Tamiflu package insert to add warnings about the potential for self-injury and confusion, particularly in pediatric patients.
Twenty-five patients younger than 21 years old have died while taking Tamiflu, with 21 of the cases occurring in Japan and three in the U.S. Five of the deaths came from children “falling from windows or balconies or running into traffic,” the FDA said.
Roche has not identified any increased risk of neuropsychiatric adverse events in patients taking Tamiflu compared with those not taking the drug, the company’s drug safety risk management director Jonathan Solsky said. Tamiflu’s current labeling continues to reflect all available data and should not change, he added.
IMPAX announces limited resumption of sales of oxycodone
STAMFORD, Conn. IMPAX Laboratories and its distributor DAVA Pharmaceuticals will resume sales of its oxycodone hydrochloride extended-release tablets in a limited capacity starting today.
This is in response to an agreement the companies signed with Purdue Pharma, who manufactures the brand version, Oxycontin, which is used for the management of moderate to severe pain when a continuous around-the-clock analgesic is needed for an extended period of time. The agreement said that IMPAX acknowledged that Purdue’s patents for Oxycontin were valid, enforceable and infringed on by their generic version. Purdue in return, allowed the companies to continue selling the product on the market until June 14, and to resume the distribution at a future date for a limited period of time.
The sales of the generic are expected to continue until around Jan. 28, 2008, or until the company’s sales quota under the license agreement with Purdue has been reached.
Isis grants Excaliard license for development of antisense drugs
CARLSBAD and ENCINITAS, Calif. Isis and Excaliard Pharmaceuticals have entered into an agreement to discover and develop antisense drugs for the local treatment of fibrotic diseases, including scarring. Isis has granted Excaliard an exclusive worldwide license for the development and commercialization of certain antisense drugs.
Under the agreement, Excaliard made an upfront payment in the form of equity and paid $1 million cash to Isis for the licensing of a particular gene target. Isis will also be eligible to receive development milestones and royalties on antisense drugs developed by Excaliard.
“Isis has made superb progress in the development of second-generation antisense drugs over the last few years, as evidenced by its clinical pipeline and current collaborations with companies such as Bristol-Myers Squibb, Eli Lilly and Ortho-McNeil, among others,” said Excaliard co-founder J. Gordon Foulkes, acting chief executive officer for Excaliard and managing director of RiverVest Venture Partners. “Having access to Isis’ antisense technology and expertise provides a great opportunity for Excaliard.”