NEW YORK (Reuters) - Roche Holding’s experimental rheumatoid arthritis drug Actemra significantly inhibited joint damage progression, according to one-year data from a two-year late stage clinical trial, the company said.
U.S. regulators have delayed approval of Actemra, considered a potential billion-dollar seller.
The company said the Food and Drug Administration had asked for more information last month related to the drug’s manufacturing and final labeling, but was not seeking more data on safety or efficacy issues.
In the study involving nearly 1,200 patients, those who received Actemra by infusion every four weeks plus an older medicine, methotrexate, experienced significantly lower progression of joint erosion and joint space narrowing than those who received methotrexate and a placebo.
Both the 8 milligram/kilogram and 4 mg/kg doses achieved statistical significance compared to the placebo group, according to data to be presented at the American College of Rheumatology meeting in San Francisco next week.
In addition, 85 percent of patients taking the higher dose and 81 percent at the lower dose experienced no progression of joint erosion or joint space narrowing compared with 67 percent in the methotrexate and placebo group, researchers said.
“The study demonstrated that treatment with Actemra inhibited structural joint damage, which is a major cause of disability and loss of physical function for RA patients,” Dr Joel Kremer, one of the Roche-sponsored study’s investigators, said in a statement.
“It is critical to stop joint damage as quickly as possible to avoid joint deformity and to help patients maintain their quality of life,” he added.
Actemra, known chemically as tocilizumab, is an anti-interleukin-6 receptor antibody and works in a different way than the existing class of biotechnology medicines that block an inflammatory protein called tumor necrosis factor (TNF), such as Roche and Genentech Inc’s Rituxan.
The most common adverse side effects experienced by Actemra patients were serious infections, which is often the case with anti-inflammatory biotechnology medicines.
The drug is being developed along with Japan’s Chugai Pharmaceutical.
Editing by Leslie Gevirtz