FDA Was Right to Delay Approving Liquidia’s Yutrepia, Judge Says

The FDA was right to delay final approval of Liquidia Corp.'s lung-disease drug Yutrepia due to United Therapeutics Corp.'s exclusivity rights for the dry-powder-inhalation version of its blockbuster Tyvaso, a federal judge ruled.

The US Food and Drug Administration’s decision to grant UTC three years of exclusivity for Tyvaso DPI was proper and Liquidia’s rival treatment fell within the scope of that exclusivity, Judge Timothy J. Kelly wrote in an opinion issued Thursday in the US District Court for the District of Columbia. He denied Liquidia’s request for summary judgment and granted cross-motions by FDA and by UTC, which intervened ...