Mesoblast gets FDA go ahead for pediatric drug


The US Food and Drug Administration has told biotechnology company Mesoblast that it now has sufficient clinical data to support a submission to approve the company’s remestemcel-L drug for treatment of pediatric patients.

Remestemcel-L is being developed for inflammatory diseases in children and adults, including steroid-refractory acute graft versus host disease, and biologic-resistant inflammatory bowel disease.

Until now the FDA had maintained that data from its Phase 3 study did not support a proposed Biologics License Application (BLA) for the drug.

Mesoblast’s shares, which have ranged wildly in price according to the state of its FDA application, jumped on the news.

The company is one of the few Australian biotechs which has raised funds to fund its own stage 3 studies which involve widespread clinical testing – something most biotechs baulk at preferring to licence their drug discoveries early in the development process.

Mesoblast CEO Dr. Silviu Itescu told investors: “We thank the agency for their collaborative approach.

“The responses and guidance from FDA are clear and provide us with a high level of confidence to refile our BLA for remestemcel-L in children with SRaGVHD.”

Mesoblast intends to file the resubmission during the next quarter, seeking to address all remaining product characterisation issues raised by the FDA.

Picture: Dr. Silviu Itescu

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