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.
Related news:
Pfizer's Rapamune Doesn't Meet Primary Endpoint in Study of Kidney Transplant Patients (Wall Street Journal)
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