Kazia Therapeutics' paxalisib receives Orphan Drug Designation from FDAQ
20 June 2022 -

Kazia Therapeutics Limited (NASDAQ: KZIA; ASX: KZA), an Australia-based, oncology-focused drug development company, announced on Friday that it has received Orphan Drug Designation (ODD) from the United States Food and Drug Administration (FDA) for the company's paxalisib to treat atypical rhabdoid/teratoid tumours (AT/RT), a rare and highly-aggressive childhood brain cancer.

ODD provides drug developers with up to seven years of Orphan Drug Exclusivity (ODE), during which competitors are not able to rely on the company's data to produce generic versions of paxalisib, effectively extending the effective life of a commercial product. It also offers opportunities for grant funding and protocol assistance, and tax credits.

The FDA is waiving fees regarding a future regulatory filing in AT/RT, potentially saving over USD3m if the company seeks approval in this indication.



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