What planet are the FDA on

What planet are the FDA on

Mesoblast ordered to conduct new trial by FDA
Tom Richardson

The US healthcare regulator the FDA has ordered Mesoblast to conduct another clinical trial to support the efficacy of its remestemcel-L drug in treating pediatric patients with severe acute-Graft Versus Host Disease (aGVHD).

"The FDA recommended that Mesoblast conduct at least one additional randomized, controlled study in adults and/or children to provide further evidence of the effectiveness of remestemcel-L for SR-aGVHD," the company said.

"The FDA also identified a need for further scientific rationale to demonstrate the relationship of potency measurements to the product’s biologic activity. Assays measuring the potency of remestemcel-L will continue to be refined to provide further scientific rationale for its use in severe inflammatory diseases with high mortality risk, such as SR-aGVHD and COVID-19 ARDS."

Investors had hoped the FDA would approve the drug on September 30 on the basis of a 9 to 1 one vote in favour of it by an oncologic advisory committee to the FDA.

Mesoblast has an ongoing trial using the same drug to treat patients with severe acute respiratory distress syndrome (ARDS) due to COVID-19.

The company also has phase 3 trials in progress attempting to develop treatments for back pain and chronic heart failure.