Posted by Michael Wonder on 10 Dec 2018
Pfenex submits new drug application to U.S. FDA seeking approval of PF708 for the treatment of osteoporosis
10 December 2018 - Submitted as a 505(b)(2) NDA with an expected ten month review.
Pfenex today announced the submission of its new drug application to the U.S. FDA seeking approval of PF708 for the treatment of osteoporosis. The application is submitted as a 505(b)(2) NDA and references Eli Lilly’s Forteo (teriparatide) as the reference listed drug.
The submission for PF708 is based on positive data from the PF708-301 Phase III clinical study announced earlier this year, which showed comparable overall profiles between PF708 and Forteo after 24 weeks of daily injection in osteoporosis patients. In addition, the NDA includes data from the PF708-101 study, a single-dose, 2-way crossover study comparing the pharmacokinetics of PF708 and Forteo in healthy subjects.
