- Healthcare stock Mesoblast (MSB) is planning to meet with the US Food and Drug Administration (FDA) for its chronic low back pain program
- Recently, the company completed a trial on 404 patients with inflammatory back pain using its stem cell drug Rexlemestrocel-L
- Now, Mesoblast wants to bring these results to the FDA in the current quarter to discuss the pathway to US regulatory approval
- On the market this morning, Mesoblast is up 4.55 per cent and is trading at $2.07 per share
Mesoblast (MSB) is planning to meet with the US Food and Drug Administration (FDA) for its chronic low back pain program.
The company recently completed a 404-patient trial using its stem cell drug Rexlemestrocel-L.
The trial tested the drug on patients with chronic inflammatory back pain due to degenerative disc disease.
Now, Mesoblast wants to bring these results to the FDA in the current quarter to discuss the pathway to US regulatory approval.
“We look forward to discussing with the FDA the most efficient path forward given the durable pain reduction for at least two years and the opioid-sparing activity from a single administration of rexlemestrocel-L that was observed in the recent phase three trial,” Chief Medical Officer Dr Fred Grossman said.
Notably, chronic low back pain affects approximately 10-15 per cent of the adult population, equivalent to more than 30 million people in the United States.
Mesoblast will use the results from a planned US trial to support potential product approvals in both the US and EU.
In line with this strategy, Mesoblast and its partner in Europe and Latin America, Grünenthal, have changed their collaboration agreement, leaving Mesoblast with US$112.5 million (around A$150 million) of funding money.
On the market this morning, Mesoblast is up 4.55 per cent and is trading at $2.07 per share at 10:09 am AEST.