Won't argue with this reporting -Mesoblast rebounds 40 per cent after US regulator approval
By Emma Koehn
Updated August 14, 2020 — 11.11amfirst published at 9.04am
Stem cell treatment producer Mesoblast has recorded a significant win after the US FDA's Oncologic Drugs Advisory Committee voted in favour of its flagship product for treating children with severe responses to bone marrow transplants.
The planned meeting of the US regulator had sent Mesoblast shares on a rollercoaster this week. The multi-billion-dollar company's share price dropped more than 30 per cent in a single session on Tuesday after briefing papers released ahead of the meeting revealed the watchdog would have serious questions about its research.
Mesoblast is hoping its MSC cells can help treat patients with COVID-19.
The expert panel had been appointed to consider whether Mesoblast's remestemcel-L product, which is also being tested on COVID-19 patients with severe respiratory distress, was effective in treating acute graft-vs-host disease in children. Graft-versus-host is a severe immune response which can occur after bone marrow transplants.
Over eight hours, the panel heard presentations from the company and experts, then grappled with the question of whether the drug was shown to be effective. The medical experts focused in particular on whether Mesoblast's study - which was "single arm", meaning it did not use a placebo - was enough to show the treatment had good efficacy.
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Several members of the panel observed that it was very difficult to recruit paediatric patients into studies that had a placebo, however, because it was hard to gain consent in cases where a child might not receive the experimental treatment.
Just after 7am AEST, the advisory committee panel placed their votes on the question of whether the data supported that remestemcel-L was effective. The votes were in favour 9 to 1.
Mesoblast shares rocketed on Friday's open, soaring 42 per cent to $4.80 by 11am in Sydney.
The decision strengthens Mesoblast's position in its path to market the treatment in the US. The committee will now advise the FDA of its view, with the regulator having until September 30 to make a formal decision on whether remestemcel-L will receive marketing approval.
Mesoblast chief executive Silviu Itescu said on a call to analysts on Friday morning the company was confident its product would be the first approved treatment of its kind in the US.
"Today Mesoblast achieved a very important step," he said. "We have built a targeted commercial sales force that’s in preparation for potential launch of the product."
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