Abbott Seeking Approval of D2E7 for Treatment of Rheumatoid Arthritis

Abbott Laboratories has requested U.S. and European regulatory approval for the human monoclonal antibody, D2E7, in the treatment of rheumatoid arthritis. If approved, it will be the first monoclonal antibody made entirely from human protein.

In 23 trials of D2E7 (adalimumab) involving more than 2,300 patients in North America, Europe and Australia, researchers focused on adults with moderate-to-severe rheumatoid arthritis who had inadequate responses to one or more disease-modifying anti-rheumatic drugs.

Human monoclonal antibodies are virtually indistinguishable from antibodies present in the human body. They mimic naturally occurring antibodies and inhibit the inflammation associated with rheumatoid arthritis.

Although there currently are drugs that use monoclonal antibodies, they either are man-made or made with a portion of mouse protein.

D2E7, an every-other week injection treatment, has been studied with and without methotrexate, as well as other traditional treatments.

At the time of submission, some patients had been taking the drug in clinical trials for more than three years.

"We have confidence in the promising data for D2E7, which reflect an evaluation in the largest number of patients in clinical trials included in regulatory submissions for an anti-TNF agent in (rheumatoid arthritis)," said Dr. Jeff Leiden, chief scientific officer of Abbott Laboratories. "It is our hope that D2E7 will provide an important and convenient treatment option for patients suffering from the debilitating effects of (the disease)."

The company expects to present Phase III trial data at upcoming medical meetings.

Other sources: Abbott