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- Mesoblast (MSB) has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for a therapy to treat complications of COVID-19
- The company’s remestemcel-L treatment is being studied for its effects on patients suffering Acute Respiratory Distress Syndrome (ARDS)
- ARDS is the leading cause of death associated with COVID-19
- Under Fast Track designation, a Biologic Licence Application (BLA) for remestemcel-L is eligible for both rolling submission and priority review
- A phase three trial of the therapy is underway, and the Fast Track designation will speed the process of review and approval if the treatment proves successful
- Mesoblast is up 11.86 per cent to $4.62
Mesoblast (MSB) has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for a therapy to treat complications of COVID-19.
In the fast lane
The company’s remestemcel-L treatment is being studied for its effects on patients suffering Acute Respiratory Distress Syndrome (ARDS) β the leading cause of death associated with coronavirus.
The FDA’s Fast Track designation speeds the development and review process for therapies which show potential to address unmet medical needs for a serious or life-threatening disease.
Under Fast Track designation, a Biologic Licence Application (BLA) for remestemcel-L is eligible for both rolling submission and priority review.
Trials have been underway since March this year, when New York’s Mt Sinai Hospital conducted a pilot study in 12 ventilator-dependent patients suffering COVID-19-related ARDS.
Nine of the patients βor 75 per cent of the cohort β 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.
Based on those positive results, a phase three trial was granted FDA Investigational New Drug clearance to proceed.
The ongoing trial in up to 300 patients is now well underway, with around two-thirds of the full cohort enrolled.
Two interim analyses have already been completed by the independent Data Safety Monitoring Board (DSMB), and the trial was given the green light from both reviews to continue as planned.
A third and final interim analysis will be conducted when 180 patients have completed the 30-day follow-up period.
The addition of the Fast Track designation will speed the FDA assessment of the trial’s outcomes, and the potential approval of the drug also be accelerated.
Next steps
Mesoblast will complete the trial as quickly as possible to finalise the data and get the ball rolling for the FDA approval phase.
The company has entered into a license and collaboration agreement with Novartis for the development, manufacture and commercialisation of the remestemcel-L therapy.
The deal means if the drug is fast-tracked to market, Mesoblast will likely have the support it needs to meet production and distribution requirements.
A lot of people will be breathing easier knowing a potential ARDS treatment could soon enter the market.
Mesoblast is up 11.86 per cent to $4.62 at 10:18 am AEDT.
