Novartis’s Drug for Hard-to-Treat MS Fails
The latest results from a late-stage study testing the effects of a drug for a hard-to-treat type of multiple sclerosis (MS) are not promising, a new study reported. According to researchers, Novartis' Gilenya was not any more effective at treating MS as the placebo.
MS is a disease of the central nervous system that is characterized by a disruption in the flow of information within the brain, and between the brain and body. Some symptoms of MS include blurred vision, loss of balance, poor coordination, tremors, numbness, fatigue and paralysis.
In the Phase III trial, researchers tested Gilenya on patients with a hard-to-treat form of MS, known as primary progressive MS. The drug has already been approved for patients with relapsing MS. The researchers compared patients' disability measures between the drug and placebo groups, and discovered no differences. Disability was assessed via limb function and walking speed. A total of 970 patients participated in the trial.
"We understand this news is very disappointing for those affected by PPMS," Vasant Narasimhan, head of development at Novartis's pharmaceuticals division, said in the statement reported by the Bloombery Businessweek. "While PPMS is a focus of the MS community, relatively little is known about the disease, so finding effective treatments remains a challenge."
The drug is being tested in two other Phase III trials as treatment for pediatric MS and chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), which is a neurological disorder that causes progressive weakness and impaired sensory capabilities in the legs and arms.
Primary progressive MS, which affects about one in 10 patients with MS, currently has no approved treatments.