Trial Profile
A Randomized Study Comparing the Effects of PF708 and Forteo in Patients With Osteoporosis
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 06 Dec 2023
Price :
$35
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At a glance
- Drugs Teriparatide (Primary)
- Indications Osteoporosis
- Focus Pharmacodynamics; Registrational
- Sponsors Pelican Expression Technology; Pfenex
- 07 Oct 2019 According to a Pfenex media release, the company is conducting a comparative human factors study between PF708 and Forteo as requested by FDA. Pfenex anticipates submitting the final study report to the FDA as early as the second half of October 2019 and believes that this completes the information package required by the FDA to evaluate the therapeutic equivalence of PF708.
- 07 Oct 2019 According to a Pfenex media release, the company announced that the U.S. Food and Drug Administration (FDA) has approved the new drug application for PF708 submitted under the 505(b)(2) regulatory pathway, with Forteo (teriparatide injection) as the reference drug.
- 08 Aug 2019 According to a Pfenex media release, the FDA has completed its mid-cycle review of NDA for PF708 in May and did not identify any issues that require an advisory committee meeting.