- Mesoblast (MSB) shares are on the rise this morning after the Oncologic Drugs Advisory Committee (ODAC) gave remestemcel-L the tick of approval
- ODAC has voted that the available data support the efficacy of remestemcel-L (RYONCIL) in pediatric patients with steroid-refractory acute graft versus host disease (SR-aGVHD)
- There is currently no treatment in the United States for children under 12 with SR-aGVHD
- Importantly, ODAC makes recommendations to the United States Food and Drug Administration (FDA)
- Mesoblast is up 37.9 per cent on the market today and is trading for $4.66
Mesoblast (MSB) shares are on the rise this morning after the Oncologic Drugs Advisory Committee (ODAC) gave remestemcel-L the tick of approval.
ODAC works with the United States Food and Drug Administration (FDA) and has voted that the available data support the efficacy of remestemcel-L (RYONCIL) in pediatric patients with steroid-refractory acute graft versus host disease (SR-aGVHD).
Acute GVHD occurs in around 50 per cent of patients who receive an allogeneic bone marrow transplant (BMT). Around 30,000 people around the globe undergo an allogeneic BMT annually, which is mainly for the treatment of blood cancers.
There is currently no treatment in the United States for children under 12 with SR-aGVHD.
The ODAC is a panel of experts that evaluates the efficiency and safety of data and makes appropriate recommendations to the FDA. The FDA will consider this recommendation, but any approvals for remestemcel-L will be made by the administrative body alone.
Chief Medical Officer Dr Fred Grossman is very pleased with today’s result.
“Steroid-refractory acute graft versus host disease is an area of extreme need, especially in vulnerable children under 12 years old where there is no approved therapy,” he said.
“We are very encouraged by today’s outcome and are committed to working
closely with the FDA as they complete their review of our submission regarding approval of RYONCIL for this life-threatening complication of an allogeneic bone marrow transplant,” he added.
The FDA will review the application on September 30 and if approved mesoblast plans to launch RYONCIL in the United States in 2020.
Mesoblast is up 37.9 per cent on the market today and is trading for $4.66 per share at 11:16 am AEST.