Approval of Orphan Drug Designation application

February 11, 2015

Plunkett Consulting, on behalf of our international client, has been assigned Orphan Drug Designation by the Therapeutic Goods Administration (TGA) for a new treatment malignant pleural mesothelioma currently in development.

As part of  this collaboration, Plunkett Consulting has prepared and submitted a comprehensive Orphan Drug Designation application to the TGA, that provides a detailed overview of the medicine along with objective evidence to demonstrate the drug is intended to treat a rare disease, as defined by the Therapeutic Goods Regulations 1990 as ‘likely to affect not more than 2,000 individuals in Australia at any time’.

Although the granting of orphan drug status in Australia is seen as not having the benefits as in the US or Europe (e.g. data exclusivity, expedited review, etc), it does permit the TGA to waive the evaluation fees, thereby reducing the cost required to being these valued treatments to market.

This approval for Orphan Drug Designation signifies the seventh successful application prepared and submitted by Plunkett Consulting staff. We have welcomed the opportunity to work on these unique, rewarding and often challenging applications where limited data available from a small number of patients is maximised to allow regulatory approval.

Contact us to discuss how our experience with drugs intended to treat rare diseases can assist in your development programs.