FDA Approves New Multiple Sclerosis Drug

(HealthDay News) — A new drug called Tecfidera has been approved to treat adults with relapsing forms of multiple sclerosis, the U.S. Food and Drug Administration said Wednesday.

The approval is based on the results of two clinical trials showing that patients who took Tecfidera (dimethyl fumarate) capsules had fewer MS relapses than those who took an inactive placebo. One of the trials also showed that a worsening of MS-related disability occurred less often in patients who took the drug than in those who took the placebo.

via FDA Approves New Multiple Sclerosis Drug.

Share

FDA Issues Warning on Controversial MS Treatment

HealthDay News — Doctors and patients need to be aware of the potential risk of injuries and death associated with an experimental treatment for multiple sclerosis called liberation therapy, the U.S. Food and Drug Administration said in an alert issued Thursday.Liberation therapy is used to treat chronic cerebrospinal venous insufficiency CCSVI — a narrowing of veins in the neck and chest — believed by some to cause multiple sclerosis MS or worsen the disease. They think it does so by impairing blood drainage from the brain and upper spinal cord.The controversial procedure uses balloon angioplasty devices or stents to widen narrowed veins in the chest and neck. But the FDA has not approved this treatment for chronic cerebrospinal venous insufficiency, and the agency said it has learned of deaths, strokes, damage to the treated vein, blood clots, cranial nerve damage, abdominal bleeding, and migration of stents in the body as a result of the treatment.

via FDA Issues Warning on Controversial MS Treatment.

Share

New Multiple Sclerosis Therapy Promising in Early Trial

(HealthDay News) — Multiple sclerosis patients may eventually benefit from a novel treatment that takes aim at the abnormal behavior of a specific type of immune cell, preliminary research suggests.

The errant behavior of the cells in question — known as "B cells" — is viewed as key to the development of this chronic and disabling nervous system disease, commonly called MS.

The new therapy’s potential is only in the early stages of exploration, cautions an international study team comprised of researchers from the United States, Canada, Switzerland and the Netherlands, in the report published in the Nov. 1 online edition of The Lancet.

via New Multiple Sclerosis Therapy Promising in Early Trial.

Share

New Pill for MS Shows Promise in Clinical Trial

HealthDay News — A new oral medication for the treatment of multiple sclerosis MS shows promise in slowing disease progression, limiting brain atrophy and reducing MS relapses, a recently completed two-year clinical trial demonstrates.The findings concern the experimental drug laquinimod, and stem from work with over 1,100 MS patients at 139 medical facilities in 24 countries.The study found that to date, the new drug appears to be both safe and well-tolerated. If the experimental medication is eventually approved for use, it would be only the second oral MS drug available to patients, alongside a number of long-standing injectable options.

via New Pill for MS Shows Promise in Clinical Trial.

Share

Merck says US rejects its MS drug

(AFP) – German pharmaceutical group Merck KgaA said Wednesday that the US Food and Drug Administration (FDA) has refused to approve use of its multiple sclerosis treatment Cladribine.

The FDA declined to approve the drug "in its present form" and asked Merck to "provide an improved understanding of the safety risks and the overall benefit-risk profile," either through additional analyses or studies.

via Merck says US rejects its MS drug – Yahoo! News.

Share