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news.Australia's Therapeutic Goods Administration has granted Alfacell Corporation's Onconase orphan drug status for the indication of malignant mesothelioma, an asbestos-related cancer.
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The Therapeutic Goods Administration (TGA) defines orphan drug products as “drugs, vaccines or in vivo diagnostic agents which physicians use to treat, prevent or diagnose rare diseases.” The TGA’s Orphan Drug Program encourages sponsors to market orphan drugs in Australia by reducing costs through waiving fees.
In addition, orphan drug status in Australia confers priority evaluation for Onconase (ranpirnase) ahead of other therapies.
Onconase, Alfacell’s lead investigational drug candidate, is also designated as an orphan drug for malignant mesothelioma (MM) in Europe and is currently being evaluated in a confirmatory phase IIIb study as a treatment for MM. Over 50 sites in the US, Canada, Europe, New Zealand and Australia are participating in the trial.
The Australian Mesothelioma Register, produced by the Epidemiology Unit of the National Occupational Health and Safety Commission (NOHSC), indicates that Australia has the world’s highest incidence rate of MM. Furthermore, incidence rates of MM have been increasing there since 1965 and there is no indication of when these incidence rates will start to decline.