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FDA approves Pfenex's osteoarthritis drug for patients at high risk of fracture

Published on 09/10/19 at 10:40am

The FDA has awarded US approval to Pfenex’s drug PF708, it has emerged, as a treatment for osteoporosis in certain patients at high risk for fracture, just like its reference product, Eli Lilly’s Forteo (teriparatide injection).

Submitted for approval last December, supporting data illustrated that PF708 showed comparable efficacy to Lilly’s drug in terms of the anti-drug antibody incidence and bone mineral density after 24 weeks of treatment.

In addition to this approval, Pfenex has requested that the FDA classify its drug as “therapeutic equivalent” to Forteo, and the company is conducting a comparative human factors study at the agency’s request. If this were to be granted, it would mean that Pfenex’s drug could be automatically substituted for Forteo in many US states.

“The FDA’s approval of PF708 marks a major milestone in Pfenex’s history as our first approved commercial product and further validates our Pfēnex Expression Technology platform. We look forward to continuing to work with our commercialisation partner Alvogen to launch PF708 in the US,” remarked Eef Schimmelpennink, Chief Executive Officer of Pfenex. “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.

“Looking ahead, we are confident in the planning that Alvogen has done thus far in preparation for the commercial launch of PF708 and their established sales and marketing teams are excited to bring PF708 to market,” he continued. “To optimise patient and payer impact, we currently expect our commercial partner Alvogen to launch PF708 upon an FDA decision on the therapeutic equivalence rating.”

Matt Fellows


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