Arthritis Pill From Pfizer Wins Support of U.S. Panel
By KATIE THOMAS - Published: May 9, 2012
A federal advisory panel recommended approval on Wednesday of a rheumatoid arthritis pill that could offer patients an alternative to the injectable medicines already on the market, but several members expressed concern about safety and urged the Food and Drug Administration to require rigorous follow-up studies.
The arthritis advisory committee voted 8 to 2 that the drug, known as tofacitinib, offered enough benefits to overcome potential safety risks, including higher rates of lymphoma and other cancers and serious infections. The agency, which is scheduled to decide on approval by August, usually — but not always — follows the advice of advisory committees.
Pfizer, which is developing tofacitinib, has hailed the drug as one of its most promising prospects as the company works to regain sales after its blockbuster cholesterol drug, Lipitor, lost its patent protection last year.
If the drug is approved, it could prove to be a potent competitor to Humira, a drug made by Abbott that brought in nearly $2 billion in sales during the first quarter of this year.
During Pfizer’s presentation to the panel, company officials said the drug’s safety risks were comparable to those of rheumatoid arthritis drugs already on the market. But an F.D.A. reviewer said his analysis showed that cancer rates in the study seemed to increase in higher doses of the drug and over time. It was these safety concerns that led two of the committee members to vote against approval.
“The observation of malignancy rates increasing over time was unexpected and is of major concern," said the reviewer, Dr. Nikolay P. Nikolov.
Pfizer is asking the agency to approve the drug in both a 5-milligram and 10-milligram dose.
In a statement, Pfizer noted that its trials included about 4,800 patients, one of the largest of its kind. “We believe the clinical trial results demonstrated a favorable benefit/risk profile and support the approval of tofacitinib,” the company said.
Pfizer has proposed that tofacitinib be prescribed only to patients for whom at least one other rheumatoid arthritis drug has failed to work.
Rheumatoid arthritis is exceedingly difficult to treat and some drugs lose their efficacy after a patient has taken them for some time. About a third of the estimated 1.3 million Americans with the disease, which causes inflammation of the joints and surrounding tissue, do not respond to existing treatments.
Tofacitinib acts in a new way in the body, by blocking the action of proteins called Janus-associated kinases. Last fall, the F.D.A. approved another so-called JAK inhibitor, Jakafi, to treat a bone marrow disease.
http://www.nytimes.com/2012/05/10/health/panel-supports-arthritis-pill.html?ref=pfizerinc
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