Pfizer is withdrawing the blood pressure drug Thelin from Europe, Canada and Australia and halting clinical trials it was conducting in a years-long quest to gain approval in the United States, the company said on Friday.
Thelin, a treatment for severe pulmonary arterial hypertension, can cause life-threatening liver problems, Pfizer said after two patients died in a clinical trial.
The Food and Drug Administration has rejected applications to market the drug in the United States at least three times in recent years, out of concern that the risks outweighed the drug’s effectiveness — concerns apparently validated by Pfizer’s announcement.
Drug companies and some business and political interests have often complained that the F.D.A. is too cautious to approve new drugs and medical devices, depriving Americans of needed treatment. Those critics say Europe has acted more in patients’ interests by approving medical advances faster.
But today’s voluntary withdrawal shows such wariness was warranted in the case of Thelin.
The drug was approved in Europe in 2006 and in Canada and Australia in 2007, even as the F.D.A. was turning back applications to bring it to American markets.
Worldwide sales of Thelin were $44.4 million in the first nine months of 2010, Pfizer said. The drug maker, which is based in New York, acquired Thelin when it bought Encysive Pharmaceuticals in 2008.
Pfizer’s decision was based on a review of emerging safety information from clinical trials and post-marketing reports. While liver toxicity is a known complication of the class of drugs to which Thelin belongs, a new potentially life-threatening idiosyncratic risk of liver injury with Thelin has been observed. Given the availability of alternate treatments, Pfizer has concluded that the overall benefit of Thelin no longer outweighs the risk in the general population of PAH patients. The Company has notified health authorities about this finding and its decision to voluntarily withdraw Thelin from the market and stop clinical studies.
“Pfizer’s priority is to ensure the safety and well-being of patients, and we are in the process of communicating all of this information to the appropriate medical professionals and regulatory authorities in all regions as quickly as possible,” said Cara Cassino, MD, vice president, Clinical Development and Medical Affairs for Pfizer’s Pulmonary Vascular Disease unit.
Pfizer recommends that no new patients be prescribed Thelin and that patients receiving Thelin be transitioned to appropriate alternate therapies as soon as safely possible according to best local practice. Patients taking Thelin or participating in Thelin studies are advised to consult with their health care professional as soon as possible. Patients should not stop taking Thelin until they speak to their health care professional.
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