The FDA approved Pfenex’s (NASDAQ:PFNX) PF708 for the treatment of osteoporosis in patients at high risk of fracture.
“The FDA’s approval of PF708 marks a major milestone in Pfenex’s history as our first approved commercial product and further validates our Pfenex expression technology platform,” CEO Eef Schimmelpennink said in a statement.
Pfenex is seeking the FDA’s designation of PF708 as therapeutically equivalent to Forteo, an FDA-approved osteoporosis treatment. The company is currently conducting a comparative study between PF708 and Forteo to support automatic substitution and plans to submit the final study report to the FDA by the end of this month.
“We believe PF708 has the potential to significantly enhance patient access to an important therapy as a cost-effective alternative to Forteo, which had $1.6-billion in global sales in 2018,” he added.