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Advisory Panel Recommends FDA Approval Of Rheumatoid Arthritis Drug

May 11, 2012

Connie K. Ho for RedOrbit.com

An advisory panel recommends that the U.S. Food and Drug Administration (FDA) consider approving Pfizer´s pill to treat rheumatoid arthritis. The pill, tofacitinib, would be sold to patients who don´t respond to traditional rheumatoid arthritis treatments. On May 9, the panel of outside experts voted 8-2 to recommend the drug for approval. However, the agency doesn´t necessarily need to follow the panel´s advice.

Tofacitinib is one of three other experimental drugs by Pfizer that need to be cleared by the FDA this year and it was voted by the panel members 10-0 to be effective.

“It improves a patient’s sense of well being. It decreases or eradicates morning stiffness,” commented Dr. Herb Baraf, a clinical professor of medicine at George Washington University, to the AFP news agency.

However, some requested to see more information on the safety of the drug if it was approved by the FDA.

“I´m a little concerned about the data showing increasing risks,” remarked Dr. Lenore Buckley, a panel member and professor at the Virginia Commonwealth University School of Medicine in Richmond, in a Businessweek Bloomberg article.

Other people were allowed to attend the public comment session and many expressed support for the Tofacitinib as they believed it would expand the patients´ choice; Enbrel or Humira, other medicines that target the immune system, are currently on the market.

“This medication will improve the care of our patients who have severe rheumatoid arthritis,” stated Dr. Daniel Mandel, a doctor with the Coalition for State Rheumatology Organizations, to AFP’s Kerry Sheridan.

If allowed to be sold on the market, Tofacitinib would bring revenue of $1.5 billion annually by 2020.

“This is as good as is possible at this stage in the game,” said Dr. David Blumenthal, a professor of medicine at Case Western Reserve University and a member of the panel, at the meeting.

According to the National Institute of Health (NIH), in 2009, rheumatoid arthritis affected around 1.3 million people in the U.S. 23.7 million people have the autoimmune disease worldwide, many of whom are women. Rheumatoid arthritis causes swelling and damage to the joints. It makes it difficult for people to walk or hold items, and the illness has been treated by anti-inflammatory pills like aspirin.

“I think the data for efficacy is compelling and it’s at least as good as other biologic agents,” explained Dr. Maria Suarez-Almazor, panel member and section chief in rheumatology at MD Anderson Cancer Center in Houston, to Reuters.

Reuters continues to describe the new drug as “a traditional chemical pill that works by blocking signals that activate immune and inflammatory responses in the body.” It would be the first in a new group of medicines called Janus Kinase (JAK) inhibitors. If approved, patients would take the drug in tablet form twice a day.

According to Businessweek, in a May 7 report, the FDA cited concerns regarding tofacitinib. Other rheumatoid arthritis treatments have had serious side effects like increased infections and cancers, particularly lymphoma. The medicines have demonstrated more cardiovascular problems and kidney toxicity.

Pfizer awaits for the FDA decision, which will be decided on August 21.

“The (rheumatoid arthritis) patient population needs additional treatment options and Pfizer looks forward to working with the FDA on next steps,” Dr. Yvonne Greenstreet, senior vice president and the head of Medicines Development Group for Pfizer Specialty Care, noted in a statement to the Chicago Tribune.


Source: Connie K. Ho for RedOrbit.com



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