By publishing key bioequivalence results on a prospect created to increase adherence to treatment regimens for kidney illness, Unicycive Therapeutics has paved the way for entering a space pursued by Sanofi and Takeda. There are several phosphate-binding medications available for chronic renal disease patients who experience hyperphosphatemia, an electrolyte imbalance linked to hospitalisation and mortality. Through its acquisition of Shire, Takeda entered the market and gained control over the Fosrenol chewable tablet market.
Related: UCB’s drug gets attention for hidradenitis suppurativa
Genzyme, now a subsidiary of Sanofi, received regulatory clearance for Renvela more than 20 years ago. Unicycive anticipates filing for FDA clearance in the middle of the year, encouraged by the findings. Only one bioequivalence study conducted on healthy participants can satisfy the clinical regulatory standards for filing under the 505(b)(2) pathway, according to FDA input, which is the basis for the approach.
Read More from FiercePharma
