April 12, 2011 -- The experimental oral multiple sclerosis (MS) drug laquinimod delayed disease progression, reduced relapse rates, and was safe and well tolerated by patients in a two-year study.
Details of the study were announced Monday by the drug’s developer, Teva Pharmaceutical Industries, at the 63rd Annual Meeting of the American Academy of Neurology in Honolulu.
A company spokesman tells WebMD that the drug met four key goals for an MS treatment by slowing disease progression, reducing relapse rates, showing a good safety profile with little evidence of immune system suppression, and being easy for patients to take.
Until recently, all the available MS drugs were given by injection. That changed last fall when the FDA approved the first oral treatment for multiple sclerosis -- Novartis’ Gilenya (fingolimod).
About 400,000 Americans and 2 million people worldwide are estimated to have MS, a neurologic disease affects the brain and spinal cord. It causes symptoms such as muscle weakness, loss of vision, and problems with balance. MS is most often diagnosed in adults under age 50.
The study of laquinimod originally included 1,106 MS patients from 24 countries who took either a once-daily 0.6-milligram dose of laquinimod or placebo for two years.
Compared to the placebo-treated patients, the patients who got the MS drug had:
23% reduction in annual relapse rates, a key indicator of drug effectiveness in MS
36% reduction in progression in confirmed disability
33% reduction in brain atrophy
Safety of Laquinimod
Jon Congleton, who is vice president of Teva’s U.S. subsidiary Teva Neuroscience, says laquinimod’s overall profile has advantages over other approved and experimental MS drugs.
Congleton says the main consideration for most doctors and patients is slowing disease progression. He says laquinimod did this and was well tolerated.
“When people in the prime of life get hit with MS, all they can envision is that wheelchair out there waiting for them,” he tells WebMD. “The best way to keep them out of that wheelchair is by slowing disease progression. This drug did this in a safe way.”
In a written statement provided to WebMD, study researcher Giancarlo Comi, MD, agrees that slowing disease progression without compromising safety is a long-standing goal of MS treatment.
Comi directs the Institute of Experimental Neurology at Milan, Italy’s Scientific Institute and University Vita-Salute San Raffaele.
“These significant results, combined with the fact that we didn’t see any safety concerns, indicate that laquinimod has the potential to be a key treatment option for MS patients,” he notes.
Neurologist Karen Shabbir-Blitz, MD, who did not participate in the study, agrees that laquinimod’s overall profile looks good, especially the safety data.
Shabbir-Blitz directs the North Shore/Long Island Jewish MS Care Center at Glen Cove Hospital, N.Y.
Given its safety profile and the fact that it is taken orally, laquinimod might be a good first treatment for newly diagnosed patients, she adds.
Teva is expected to present results from another study of laquinimod later this year. The company plans to file for FDA approval for the treatment of relapsing/remitting MS after that.
Congleton says the drug could be on the market by late next year or early 2013.