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Pfizer Arthritis Pill In Trouble With FDA Over Safety Concerns

Pfizer's new drug raises concerns in FDA trials

Pfizer has a new pill to treat rheumatoid arthritis, but U.S regulators in the FDA say that the experimental pill raised some “serious safety concerns” in its trials.

Tofacitinib is meant to treat rheumatoid arthritis, but actually carried increased risks of serious infections and other malignant problems in its trials. In particular, the Food and Drug Administration found that the pill increases a patient’s chance to develop lymphoma.

FDA staff also noted that the pill didn’t even do what it was supposed to do – stop the progression of rheumatoid arthritis, an auto-immune disease that causes deterioration in the joints. “This is particularly important in determining the overall benefit-risk profile of tofacitinib, which is associated with serious safety concerns.”

Pfizer’s tofacitinib would be the first rheumatoid arthritis pill to hit the market in decades, with Pfizer president of specialty care calling it the “greatest unmet need [that] exists today,” in a conference call. The experimental pill is projected to be a major cash-cow for Pfizer, and negative reaction from the FDA is, in a way, to be expected. “We expected a tough AdCom and the summary and questions reflect the FDA’s hard look at both tofa’s efficacy and safety,” said Mark Schoenebaum, an analyst with ISI Group in New York.

“We see about a 5 percent downside to the stock, maybe $1, if the thing is completely rejected,” he continued.

He further noted that Pfizer’s difficulty with the FDA is due to an increased effort for stricter approval guidelines, especially with other treatments for rheumatoid arthritis available on the market. “Because it’s not as much of an unmet medical need as it was a few years ago, the requirements have gone up,” he concluded.

The final ruling on t0facitinib by the FDA is expected in August. You can read the full FDA staff report here.

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