Commercial stage biopharmaceutical company Hutchmed (HCM:AIM) said its pancreatic tumor drug surufatinib had failed to be approved by the US FDA (Food & Drug Administration), sending the shares 15% lower to 208p on Tuesday.
The FDA originally accepted the company’s new drug application submission on 30 June 2020 which was based on two positive late stage trials in China along with a bridging study completed in the US.
The US regulatory body has now determined it needs a ‘multi-regional’ trial for surufatinib to be approved in the US.
In its response letter the FDA said it required data based on patient studies ‘more representative of the US patient population and aligned to current US medical practice.’
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CEO Weiguo Su commented: ‘Although this decision from the FDA is disappointing, we remain confident about the clinical value of surufatinib for NET patients and committed to making surufatinib available to patients globally.
‘There are very few treatments approved and used in these rare diseases, and patients and physicians would benefit from more options to address the unmet medical need. We look forward to continued engagement with the FDA on developing a plan to bring surufatinib to patients in the U.S.’
Surufatinib has already been granted drug registration approval in China to treat patients with pancreatic and extra-pancreatic tumors.
The company said its global development strategy remains unchanged. It has submitted a marketing authorisation application with the EMA (European Medicines Agency) which is currently under review.
