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Relief announces US FDA denies breakthrough designation to NRx Pharma’s aviptadil

Geneva, Switzerland
Thursday, November 25, 2021, 16:00 Hrs  [IST]

Relief Therapeutics Holding SA (Relief), a biopharmaceutical company, reported that the parent company of its collaboration partner, NRx Pharmaceuticals, Inc. (NRx), has issued a CEO Update announcing that the US Food and Drug Administration (FDA) has denied Breakthrough Therapy Designation (BTD) for aviptadil.

NRx noted that BTD is not required for drug approval or emergency use authorization, but can afford faster review times, the ability to submit a rolling application, and dedicated FDA review personnel who may interact more frequently with the sponsor. Additionally, according to the CEO Update, the FDA has already granted priority and rolling review as part of the Fast Track Designation awarded in July 2020. Therefore, the denial does not impede NRx’s ability to seek drug approval, although it does identify areas where NRx needs to seek better scientific alignment with the FDA.  

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale.

 

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