Dicerna Pharmaceuticals announced the submission of an updated investigational new drug, or IND, application to the FDA for DCR-PHXC, the Company’s lead GalXC product candidate for the treatment of all forms of primary hyperoxaluria, or PH. The update reflects agreement on the primary endpoint for the PHYOX 2 pivotal clinical trial, which is enrolling patients with PH type 1, or PH1, and PH type 2, or PH2, and alignment with the FDA regarding the path to full approval for the treatment of patients with PH1, as conveyed during a recent FDA Type A meeting. The Company will continue its ongoing dialogue with the FDA regarding endpoints for studies involving patients with PH2 and PH3, as part of the PHYOX clinical development program for DCR-PHXC.
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