Drugs

FDA Denies Petition Seeking to Block Liquidia NDA

FDA has denied a United Therapeutics citizen petition that asked it to withdraw tentative approval of a Liquidia Technologies NDA for Yutrepia (treprostinil) and issue a complete response letter instead. The 5/10 petition said that LGM Pharma, which United says is Liquidia’s sole active pharmaceutical ingredient (API) supplier, is the subject of an ongoing consent decree in which it admitted liability for committing serious and pervasive violations of the current good manufacturing practice requirements in connection with its handling and processing of APIs for finished drug product manufacturers like Liquidia. “Unless and until Liquidia successfully completes all steps required by the consent decree or finds a safe alternative to LGM, there can be no assurance that Yutrepia is not tainted,” the petition argued.

In response, FDA says it does not agree that recission of the tentative Yutrepia approval is warranted. While the petition indicates that LGM is the sole supplier of the treprostinil sodium API, the agency says this is incorrect and that YS Life Science Co. is Liquidia’s sole treprostinil sodium manufacturer. “Further, Liquidia has informed FDA that, beginning on 2/14, shipments of treprostinil sodium have been and will be sent directly from Yonsung to Liquidia,” the agency response says. “LGM will not be involved in the physical handling of the shipments and will not store or warehouse treprostinil sodium.”

Additionally, FDA says it is unwarranted to issue a complete response letter on the Yutrepia NDA because it has reviewed relevant information on the manufacturing, processing, packing, and holding of Yutrepia and it has found that “while LGM is subject to obligations under a consent decree, Liquidia has indicated that all future shipments of treprostinil sodium will be shipped directly from Yonsung to Liquidia and will not be stored or warehoused at an LGM facility.” It further notes that because LGM does not store or warehouse the treprostinil sodium, LGM’s obligations under the decree are not relevant to the Yutrepia NDA.

According to Liquidia, FDA has acknowledged United Therapeutics’ regulatory exclusivity for Tyvaso DPI “that encompasses chronic use of essentially any dry-powder formulation of treprostinil in the approved indications for a three-year period for its new dosage form approved on 5/23/2022. We plan to take quick action to challenge the FDA’s broad grant of regulatory exclusivity and defend the ability for patients to have access to Yutrepia with the least delay possible.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

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