Mesoblast Cell Therapy Gets RMAT Designation for Chronic Low Back Pain
The FDA has granted regenerative medicine advanced therapy (RMAT) designation for Mesoblast’s rexlemestrocel-L in the treatment of chronic low back pain associated with disc degeneration, in combination with hyaluronic acid as a delivery agent for injection into the lumbar disc.
The designation for the allogeneic cell therapy was based on data from a phase 3 trial of 404 patients showing that a single injection of rexlemestrocel-L into the lumbar disc resulted in significant reduction in pain compared with saline control at 12 and 24 months across all subjects.
Low back pain is the fifth most common reason for visiting a U.S. doctor and is one of the leading causes of disability. An effective new treatment for the condition could reduce the amount of opioids currently prescribed for it.
RMAT designations aim to expedite the development of regenerative medicine therapies intended to treat a serious condition when preliminary clinical evidence indicates that the drug has the potential to address unmet medical needs. The designation includes eligibility for priority review on filing of a biologics license application.
About Chronic Low Back Pain Caused By Degenerative Disc Disease
Over 33 million patients in the U.S. alone suffer from CLBP with approximately 22% caused by degenerative disc disease. The patient population suffering from chronic low back pain due to intervertebral disease is estimated at more than 3.2 million patients in the U.S. alone. Total costs of low back pain in the U.S. are estimated at between US$100 billion and US$200 billion annually with two thirds of these costs attributed to patients’ decreased wages and productivity.
All approved therapies for progressive, severe and debilitating pain due to degenerating intervertebral discs treat the symptoms of the disease, but are not disease-modifying and thus do not address the underlying cause of the disease.
Limited treatment options exist for patients who have failed conservative treatment such as physical therapy, anti-inflammatory agents or analgesics as well as other measures including opioids and epidural steroid injections. In the United States, approximately 50% of opioid prescriptions are for chronic low back pain.
When disc degeneration has progressed to a point that pain and loss of function can no longer be managed by conservative means, major invasive surgery is the only remaining option. Even with surgical intervention such as spinal fusion or artificial disc replacement, between 30-46% of patients are considered treatment failures.
About Mesoblast Limited
Mesoblast Limited is an Australian-based regenerative medicine company. It seeks to provide treatments for inflammatory ailments, cardiovascular disease and back pain. The company is led by Silviu Itescu, who founded the company in 2004. Headquarters: Melbourne, Australia
February 10, 2023
