Arthritis Drug
From Roche
Dealt Setback
By JEANNE WHALEN
SEPTEMBER 19, 2008
The U.S. Food and Drug Administration delayed approving Roche Holding AG's arthritis drug Actemra, asking the Switzerland-based drug maker for more information about the product, Roche said.
Actemra, one of Roche's most important new products, treats rheumatoid arthritis in a new way. It is an injectable drug that blocks a protein in the body called IL-6, which plays a role in inflammation.
Some analysts have said that Actemra eventually could achieve annual sales of more than $1 billion.
The FDA is asking for extra information about the manufacturing of Actemra and other issues such as the drug's final label, Roche said.
The FDA isn't asking for extra information about the drug's safety or efficacy, Roche said. Nor is the FDA requesting extra clinical trials of the drug, Roche added.
"We are confident that we will be able to resolve these matters with the agency in the near future," William Burns, chief executive of Roche's pharmaceutical division, said.
Roche's partner, Chugai Pharmaceutical Co., of Japan, began selling Actemra as an arthritis treatment in Japan this year.
The partners are awaiting regulatory approval in Europe and the U.S
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