Data show no stroke risk with Pfizer lung drug: FDA (Reuters)
Posted by admin
Favorable results from the trial contrast with retrospective pooled analyses of dozens of previous studies that had suggested a higher risk of stroke among patients seizing the once-daily inhaled medicine.
The FDA said a clearer picture of the drug's safety will not be available till it receives and analyzes final data from the new formal study, which involved almost 6,000 patients by chronic obstructive pulmonic disease (COPD). The condition, which is highly linked to smoking (just quit smoking - try stop smoking patch), involves bronchitis and emphysema.
The FDA in March had cautioned patients and doctors from one place to another the possible complication of stroke after a company analysis of 29 clinical trials showed a greater risk in those taking the medicine.
Concern about possible risks of the drug intensified last month, when a separate analysis of pooled data from 17 between nations studies suggested the medicine raises the risk of heart attack, stroke and death from passion disease. The analysis was performed by dint of. independent investigators.
But results from the new 4-year trial, known as Uplift, showed no such risk for Spiriva, Pfizer and its marketing partner Boehringer Ingelheim said last month. The drugmakers sponsored the trial.
"The preliminary results of Uplift reported by Boehringer Ingelheim to the FDA showed that there was no increased risk" with Spiriva, the FDA said on Tuesday.
The agency said it expects to receive complete data from the Uplift trial next month, and it will likely take another several months to review the results and report its own interpretations of the findings.
Late in the session attached a roughly lower New York Stock Exchange, Pfizer shares were off 98 cents or 5.2 percent at $17.96.
(Reporting by Susan Heavey and Ransdell Pierson in New York, editing by Gerald E. McCormick)
Leave a Reply