Pfizer’s kidney drug misses phase 3 goal
Pfizer’s kidney drug Rapamune did not meet its primary endpoint in phase 3 clinical trials.
The trials of Rapamune (sirolimus) were evaluating kidney transplant patients who transitioned from tacrolimus-based therapy (TAC) to Rapamune 3 to 5 months after transplant.
The primary endpoint of the study was not achieved as there was not a statistically significant difference in renal function improvement between patients who continued receiving TAC and those who switched to Rapamune.
For patients who were switched to Rapamune, 33.7% of patients achieved the primary endpoint of a ≥ 5 ml/min/1.73m2 renal function improvement based on glomerular filtration rate (GFR) from randomization to 24 months post-transplantation and 42.3% of patients continuing to take TAC achieved the primary endpoint (p=0.239).
In the United States, Rapamune is indicated for the prevention of organ transplant rejection in kidney transplant patients aged 13 years and older.
Pfizer’s Rapamune Doesn’t Meet Primary Endpoint in Study of Kidney Transplant Patients (Wall Street Journal)
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