FDA panel favors novel arthritis drug from Pfizer
Thursday, May 10, 2012
WASHINGTON (AP) — Federal health advisers said Wednesday that a first-of-a-kind drug from Pfizer appears to be safe and effective for patients with rheumatoid arthritis, though they recommended follow-up studies to gauge the pill's long-term side effects.
The Food and Drug Administration's panel of arthritis experts voted 8-2 in favor of Pfizer's tofacitinib for patients who have not responded to one or more other drugs. The FDA is not required to follow the group's advice, though it often does. A final decision is expected in August.
Panelists said the drug could be an important option for patients, but voiced concern over reports of lymphoma and infection among patients taking the pill. Assessing the drug's role in those problems is difficult because patients with rheumatoid arthritis are already predisposed to a range of health problems, including cancer.
If approved, tofacitinib would be the first pill for rheumatoid arthritis from a new class of pain medications called JAK inhibitors. The drugs work by interfering with enzymes that contribute to the inflammation process that causes joint pain, particularly in the hands and feet.
Studies conducted by Pfizer showed patients improved 20 percent or more on a medical questionnaire that measures arthritis pain and symptoms. However, the FDA said the company's results were less conclusive on another measure: X-ray images tracking the rate of joint damage.
Despite that shortcoming, panelists said Pfizer's pill could be an important option for patients who haven't responded to other drugs or aren't comfortable with injectable medications.
"I voted yes because I would like to have this drug available for rheumatoid arthritis patients, given that we know a third of them will not respond to available therapies," said Dr. Maria Suarez-Almazor of the MD Anderson Cancer Center in Houston.
For more than a decade, rheumatoid arthritis has been treated with injectable drugs like Humira, which block a messaging protein related to inflammatory diseases. Humira and rival Enbrel were the 10th and 11th best-selling drugs in the U.S. last year, with combined sales of $7 billion, according to IMS Health. The drugs are also prescribed for psoriasis and other diseases of the immune system.
Rheumatoid arthritis occurs when the immune system attacks the body's own joints and tissue. It differs from traditional arthritis, which is caused by long-term deterioration of bones and joints.
The most common side effects of treatment with tofacitinib have included bronchitis, headache, infections, and gastrointestinal symptoms like nausea, vomiting, and diarrhea. More serious side effects include higher cholesterol levels and increased creatinine levels.
Tofacitinib is a key product in Pfizer's pipeline, following patent expirations on several blockbuster drugs, including the world's best-selling prescription medication, Lipitor. Pfizer is studying tofacitinib as a potential treatment for psoriasis, inflammatory bowel disease, and renal transplant.
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