Pfenex Announces FDA Requests Additional Comparative Use Human Factors Data in Experienced Users in order to Complete PF708 Therapeutic Equivalence Determination
PFENEX INC (PFNX)
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pfenex.com
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Source: GlobeNewswire
SAN DIEGO, April 14, 2020 (GLOBE NEWSWIRE) -- Pfenex Inc. (NYSE American: PFNX) announced today that the U.S. Food and Drug Administration (FDA), informed Alvogen Malta Operations Ltd., the Company’s commercialization partner for PF708, via a General Advice letter that additional comparative use human factors (CUHF) data, specifically from Forteo® (teriparatide injection) experienced users, would be required before PF708 Therapeutic Equivalence (TE) could be determined. “While the previously submitted CUHF study included Forteo-experienced patients and caregivers, the FDA requested that a larger number of experienced subjects be studied,” stated Eef Schimmelpennink, Chief Executive Officer of Pfenex. “In the correspondence the FDA has indicated that the review of the PF708 TE package continues and provided guidance on study methodology to generate this additional comparative use human factors data, which we are confident can be met. We intend to work closely with Alvogen and the FD
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