A COVID-19 treatment being developed by Australian pharmaceutical company Mesoblast (ASX: MSB) has been granted Fast Track designation by the US Food and Drug Administration (FDA) today.
The designation is for MSB's treatment of acute respiratory distress syndrome (ARDs) - a potentially fatal complication of COVID-19 infection called remestemcel-L.
As a result, the FDA will assist in the development of remestemcel-L and will expedite the review of the drug because it fills an unmet medical need.
Under Fast Track designation, a Biologic License Application (BLA) for remestemcel-L is eligible for both rolling submission and priority review.
In its submission to the FDA Mesoblast highlighted results from a pilot study of remestemcel-L under emergency compassionate use at New York's Mt Sinai Hospital in March-April this year.
In this study, nine of 12 ventilator-dependent patients with moderate to severe COVID-19 ARDS were successfully discharged from hospital a median of 10 days after receiving two intravenous doses of remestemcel-L.
An ongoing Phase 3 trial of the drug in up to 300 ventilator-dependent patients is approximately two thirds enrolled.
Two interim analyses of this trial have been performed by the independent Data Safety Monitoring Board (DSMB), with recommendations to continue the trial.
Receipt of the Fast Track designation comes after Mesoblast entered into a license and collaboration agreement with Novartis for the development, manufacture and commercialisation of remestemcel-L.
As part of the deal Switzerland-based Novartis will make a US$50 million (AUD$68.7 million) upfront payment to Mesoblast.
Following the initiation of a Phase 3 clinical trial, Novartis will fully fund the global clinical development of the drug.
In addition, Mesoblast may receive a total of US$505 million (AUD$694 million) pending achievement of pre-commercialisation milestones for remestemcel-L and a further US$750 million (AUD$1 billion) based on achieving certain sales milestones.
Mesoblast will retain full rights for the use of remestemcel-L for treatment of graft versus host disease.
Updated at 9.58am AEDT on 2 December 2020.
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