The Food and Drug Administration (FDA) has approved ‘PF708’ (Pfenex) for the treatment of osteoporosis in certain patients at high risk for fracture.
The application was approved through the Agency’s 505(b)(2) pathway; this regulatory route allows the applicant to submit information from studies conducted by a separate entity and for which the applicant has not obtained a right of reference. For PF708, Pfenex used Forteo (teriparatide injection; Eli Lilly) as the Reference Listed Drug.
The approval is based on data from the PF708-301 phase 3 study which showed comparable overall profiles between PF708 and Forteo after 24 weeks of daily injection in osteoporosis patients.
The Company is currently conducting another comparative study between PF708 and Forteo, with the aim of having the treatment designated as a therapeutic equivalent (‘A’ rated) to Forteo. They hope to submit the final results from this study to the FDA “as early as the second half of October 2019.”
“We believe PF708 has the potential to significantly enhance patient access to an important therapy,” said Eef Schimmelpennink, CEO of Pfenex.
Alvogen is responsible for commercialization and manufacturing PF708 in the US and for fulfilling all regulatory requirements associated with maintaining the PF708 NDA.
For more information visit pfenex.com.
This article originally appeared on MPR