Bivictrix Therapeutics PLC on Wednesday said its BVX001 drug has been granted special status by the US Food and Drug Administration.
The Macclesfield, England-based biotechnology company focused on cancer therapies announced that the US FDA had granted an Orphan Drug Designation for the treatment of acute myeloid leukaemia to the company’s lead asset BVX001.
FDA ODD gives an orphan status to therapies for the prevention, diagnosis or treatment of diseases affecting less than 200,000 people. The designation entitles sponsors of the therapy to financial incentives like tax credits for qualified clinical trials, prescription drug user fee exemptions and potential seven-year marketing exclusivity.
Bivictrix completed an initial targeted engagement for regulatory advice meeting with the FDA Centre for Drug Evaluation & Research, for guidance on BVX001’s pharmacology, toxicology and chemistry, manufacturing and controls.
This was in preparation for filing an investigational new drug application.
Bivictrix Chief Executive Officer Tiffany Thorn said: ‘The ODD grant for our lead asset BVX001 represents important US regulatory progress for Bivictrix, highlighting the significant unmet need for novel therapies targeting acute myeloid leukaemia and providing us with greater market exclusivity potential.’
Bivictrix Chair Michael Kauffman said: ‘Early engagement with the FDA for novel therapeutic approaches is key, and I am delighted with our progress to date. Our ability to qualify for an INTERACT meeting underscores the novel and compelling approach we are taking with our scientific platform to develop truly differentiated therapies in areas of high unmet need, as demonstrated by our ODD.
‘I am confident that BVX001 has unique and novel attributes that will support its advancement to the clinic. This timely FDA guidance and ODD will expedite BVX001’s development, as we look to work closely with the FDA and other regulatory agencies.’
Bivictrix shares were up 2.6% to 11.54 pence each in London on Wednesday afternoon.
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