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Pfenex And Alvogen May Face Delay In Teriparatide Equivalence Rating

 
• By Aidan Fry

Pfenex remains hopeful of receiving US approval for its teriparatide hybrid rival to Eli Lilly’s Forteo in October this year. But commercial partner Alvogen may have to wait for a therapeutic equivalence rating to the osteoporosis original.

Delayed
Obtaining a therapeutic equivalence rating for Pfenex' hybrid teriparatide device in the US could be delayed by a lack of FDA feedback on a study protocol • Source: Shutterstock

Pfenex and commercial partner Alvogen could face a delay in obtaining an ‘A’ therapeutic equivalence rating for the 505(b)(2) hybrid rival to Eli Lilly’s Forteo teriparatide brand for which they hope to obtain US approval in early October. The US Food and Drug Administration recently told Pfenex that it might be premature to comment on the firm’s protocol for a comparative human factors study for the drug-device combination until the label details for the PF708 teriparatide candidate have been agreed, which may be close to the osteoporosis treatment’s Prescription Drug User Fee Act target date of 7 October 2019.

Stressing that it was discussing the situation with the agency, Pfenex admitted: “Depending on the outcome, it may delay the start of the study, submitting the study results to the FDA, and potentially obtaining a therapeutic equivalence rating, if at all

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