Drug company Celgene recently announced results from two phase III trials evaluating the efficacy and safety of the drug ozanimod and is now seeking approval from the U.S Food and Drug Administration (FDA).
Ozanimod is a new oral drug for patients with relapsing remitting multiple sclerosis (RRMS). The findings from the two phase III trials, titled SUNBEAM and RADIANCE Part B, have paved the way for the drug to enter the FDA’s new drug approval process.
Treating inflammation in RRMS patients is key to reducing relapses or ‘flare ups’. Ozanimod works by blocking sources of inflammation in the patient’s lymph nodes and preventing the inflammatory cells from entering the brain and spinal cord. As a result it is able to stop attacks that cause damage to myelin.
The RADIANCE Part B study evaluated two doses (1mg and 0.5mg) of oral ozanimod compared with Avonex (interfernon beta-1a) in 1,320 patients with RRMS in 21 countries treated for two years. The SUNBEAM study evaluated two doses (1mg and 0.5mg) of oral ozanimod in 1,346 patients with RRMS in 20 countries treated for at least one year.
Ozanimod demonstrated a significant 48% reduction in new or enlarging T2 lesions over one year when taking 1mg and a 25% reduction in patients given 0.5mg compared with Avonex.
Patients taking 1mg of ozanimod showed a significant 63% reduction in gadolinium-enhanced MRI lesions at one year and patients taking 0.5mg showed a 34% reduction compared with Avonex. Ozanimod significantly slowed the loss of brain volume compared with Avonex, a hallmark of the disease that causes brain atrophy, disease progression and cognitive impairment.
'Ozanimod's ability to inhibit brain atrophy promises patients a long and productive life, living with RRMS without disability," said TSRI Professor of Molecular Medicine, Hugh Rosen, co-inventor of ozanimod. "This is truly disease-modifying.'