Parsabiv etelcalcetide regulatory update

FDA issued a complete response letter to Amgen for an NDA for Parsabiv etelcalcetide to treat secondary hyperparathyroidism in adults with chronic kidney disease (CKD) on hemodialysis. Amgen declined to disclose the concerns raised by the agency, but said it hopes to meet with FDA this year to discuss the letter. Parsabiv is a peptide calcimimetic that acts on the parathyroid gland to reduce production of parathyroid hormone (PTH). In September 2015, Amgen submitted an MAA to EMA for the product.

The IV therapy met the primary endpoints in 3 Phase III trials, including 2 placebo-controlled trials and a head-to-head trial vs. Sensipar/ Mimpara cinacalcet, an oral second-generation calcimimetic that Amgen markets in the U.S. and EU (see BioCentury, July 21, 2014, Sept. 1, 2014 & March 2, 2015). Amgen said patent coverage extends into March 2018 for Sensipar, which is approved in the U.S. to treat secondary hyperparathyroidism and hypercalcemia. ...