Avacta's soft tissue sarcoma treatment gets FDA orphan drug designation
Avacta Group
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16:55 14/11/24
Biotechnology company Avacta Group said on Monday that its soft tissue sarcoma treatment has been granted orphan drug designation by the US Food and Drug Administration.
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Avacta stated the ODD grant for its lead pre|CISION drug candidate, AVA6000, a form of the generic chemotherapy doxorubicin, was based on a review of pre-clinical data from investigational treatments for rare diseases.
The London-listed firm said the designation qualifies the developer of the drug for certain incentives, including seven years of market exclusivity upon drug approval from the FDA.
Chief executive Dr Alastair Smith said: "We are delighted to receive Orphan Drug Designation from the FDA for AVA6000, which is a reflection of the high quality of the preclinical data and the potential benefit the pre|CISION platform can bring to cancer patients.
"This designation provides tax credits and other incentives for drug developers addressing rare diseases. Most notably the Orphan Drug Designation will give Avacta, if AVA6000 is approved for treatment of soft tissue sarcoma, seven years of market exclusivity in the US, which is a significant commercial advantage."
As of 1000 BST, Avacta shares were up 5.09% at 122.95p.
Reporting by Iain Gilbert at Sharecast.com