U.S. FDA advisers back Pfizer arthritis drug
WASHINGTON (Reuters) - Pfizer Inc won a U.S. advisory panel's support on Wednesday for its arthritis drug.
A panel of outside experts to the U.S. Food and Drug Administration voted 8-2 to recommend approval of tofacitinib, meant to treat patients with rheumatoid arthritis who have not had success with at least one other drug for the disease.
The FDA usually follows panel recommendations, although it is not required to do so, and a final decision is expected in August.
If approved, the likely cheaper pill would compete with widely used injectable medicines, including Abbott Laboratories Inc's $8 billion-a-year biologic drug Humira.
"I think the data for efficacy is compelling, and it's at least as good as other biologic agents," said Dr. Maria Suarez-Almazor, panel member and section chief in rheumatology at MD Anderson Cancer Center in Houston.
However, most panelists said the drug should only be used once patients had tried at least several other drugs for the disease. They expressed concern about some of its side effects, such as infections and malignancies, or tumors that can spread.
Rheumatoid arthritis and related diseases have been one of the most lucrative areas for drugmakers, with more than $20 billion in annual sales.
An estimated 1.3 million Americans suffer from rheumatoid arthritis, according to the Arthritis Foundation. About 1 percent of the world's adult population has the disease.
Besides Humira, other treatments include Enbrel, made by Amgen Inc, and Johnson & Johnson's Remicade. All of these are costly, injectable drugs that block a protein called tumor necrosis factor (TNF) that is tied to inflammation.
Pfizer's treatment is a traditional chemical pill that works by blocking signals that activate immune and inflammatory responses in the body. It is the first in a new class of drugs called JAK inhibitors.
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