Pfizer Says One Clinical Trial Death Associated with Experimental RA Drug

During a clinical trial for <"">tofacitinib, an experimental rheumatoid arthritis (RA) medication, one death has been reportedly linked to the drug, said Bloomberg News. The experimental RA drug is under trial by Pfizer Inc. and this death represents one of four that have occurred during this trial and which can be connected to the medication, according to a just-released Pfizer statement.

After a summary report was released online that indicated that not only four deaths, but four infections, took place during clinical trials for the drug—tofacitinib, Pfizer shares took a dramatic drop, the most since August, noted Bloomberg News. No significant adverse events were seen in the group taking the placebo, wrote Bloomberg News, citing the study abstract, which is scheduled to be presented at the European League Against Rheumatism, which will meet in London, England.

At least one analyst minimized the deaths, saying, “It’s a big overreaction,” quoted Bloomberg News. David Maris, an analyst with CLSA in New York, who spoke to Bloomberg News in a telephone interview, added that investors “saw four deaths and flipped out, and as they start to digest this a little more they’ll realize it doesn’t appear to be as bad as people thought.”

One participant died from respiratory failure and that death was directly related to tofacitinib, said Pfizer said in a press release, wrote Bloomberg News. Business Week noted that the three other deaths have not yet been connected to the experimental RA drug. Pfizer is the world’s largest drug manufacturer.

“There are no serious events in the control arm, and then you have a bunch of adverse events; people are going to question the safety of the drug,” Les Funtleyder, a New York-based fund manager at Miller Tabak & Co. in New York, told Bloomberg News in a telephone interview. “Really we need to get more data. It may not be statistically significant. But that may not even matter because people are so sensitive about safety concerns these days,” Funtleyder added.

The study was watching 792 patients with RA who saw no improvement on other medications, said Bloomberg News, which said the other deaths involved a brain injury following a trauma, a case of worsening RA when the drug was stopped, and one case of acute heart failure, according to the Pfizer statement. Business Week pointed out that over 1,000 patients have taken tofacitinib in the clinical trials.

Formerly called tasocitinib, tofacitinib is being tested for the treatment of moderate to severe RA, said Business Week.

RA is, described Business Week, a chronic autoimmune disease that leads to inflammation, typically of the hands and feet. Pfizer is in competition with other firms to develop the first medication in about 10 years for RA, which ruins the joints and afflicts about 1.3 million Americans, wrote Bloomberg News. Tofacitinib is in a class of experimental medications that targets JAK, a protein linked to joint devastation and the most superior medication in this class at this time, wrote Bloomberg News.

According to Pfizer, the study’s death rate is similar to the death rate seen in other treatments for RA.

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