BIOTA'S Relenza royalty prospects have been dealt a new blow after a US Food and Drug Administration advisory panel recommended that the flu drug carry warnings about the potential for psychiatric side effects from the drug. According to Associated Press reports in the US, the panel voted eight to six in favour of urging the FDA to ensure warnings are placed that say psychiatric problems seen in a handful of patients have sometimes proved fatal.
Relenza
If the FDA accepts the recommendations it will be the first time that Relenza has carried such a warning. The label for Relenza's major competitor, Tamiflu, already mentions reports of delirium and self-injury, primarily among children in Japan, but the FDA panel recommended that the language should inform users that several patients have died as a result of these abnormal behaviours.
While the warnings have the potential to hit sales, the committee did not make a finding on whether the psychiatric problems are a side effect of the drug or of the flu itself.
Roche has consistently denied that Tamiflu is the cause of any side effects, and Biota chief executive Peter Cook told BTN in an interview earlier this month that the drug developed by his company and distributed by GlaxoSmithKline had not been associated with any adverse psychological events.
"All of the evidence is that this is a reporting problem that is unique to oseltamivir [Tamiflu], that it's a problem associated with that drug, not the class of drugs," he said.
"Having said that, when oseltamivir so dominates the sector there's a tendency for this to be seen as a neuraminidase inhibitor problem, not an oseltamivir problem, and that's an issue."
Cook was speaking to BTN about reports that Roche's Japanese manufacturer was intending to halve production of Tamiflu due to reports of adverse events associated with the company's drug.
Nearly 600 cases of psychiatric problems have been reported in Tamiflu patients, with 75% of them coming from Japan. Five children there have died after "falling from windows or balconies or running into traffic", according to the FDA.
Roche presented its own analysis to the committee, with data involving more than 150,000 patients whom the company said showed no connection between Tamiflu and increased risk of psychiatric problems.
"Emerging evidence suggests that influenza itself may cause neuropsychiatric adverse events," Roche said in a statement.
According to the Associated Press report, some of the panellists considering the warning argued that the labelling should be softened slightly by pointing out that similar deaths have also occurred in flu patients not on medication.
Cheers dma
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