United Therapeutics' Challenges FDA Over Liquidia's Drug Approval Process, Clocks Strong Q4 Earnings

Wednesday, United Therapeutics Corporation UTHR initiated legal action against the FDA, claiming that the FDA wrongly allowed Liquidia Corporation LQDA to deviate from established rules in the drug approval process. 

The litigation focuses on the FDA’s handling of Liquidia’s amendment to a pending new drug application (NDA) related to its proposed inhaled dry powder treprostinil product, seeking to add a second indication for pulmonary hypertension associated with interstitial lung disease (PH-ILD). 

Also Read: This United Therapeutics Analyst Is No Longer Bearish, Expects Mid-Decade $4B Revenue Run Rate.

United Therapeutics contends that FDA rules require a new NDA for such a second indication rather than an amendment to an existing one.

The company also asserts that, under the Hatch-Waxman Act, Liquidia’s decision to file an amendment instead of a new NDA allowed it to avoid a potential 30-month stay on approval for PH-ILD. 

This stay would be triggered if a timely patent infringement action is filed, preventing FDA approval until the litigation is resolved. 

United Therapeutics had previously sued Liquidia for alleged infringement of a patent related to the PH-ILD indication. 

The ongoing patent infringement case contends that Liquidia’s actions in seeking approval for PH-ILD infringe on United Therapeutics’ patent rights. 

The lawsuit is pending in the U.S. District Court for the District of Delaware. 

If successful in its legal action against the FDA, United Therapeutics aims to secure a stay of up to 30 months on Liquidia’s final approval for PH-ILD, allowing for the resolution of the patent infringement litigation.

United Therapeutics reported a fourth-quarter 2023 EPS of $4.36, up from $2.67 a year ago, beating the consensus of $4.19.

The company’s sales increased 25% to $614.70 million, beating the consensus of $575.87 million.

Total Tyvaso revenues grew by 45% to $350.6 million in the fourth quarter of 2023, compared to $242.3 million a year ago, primarily due to an increase in quantities sold, driven by the commercial launch of Tyvaso DPI in June 2022 and continued growth in utilization by PH-ILD patients.

Price Action: UTHR shares are up 0.87% at $216.03 on the last check Wednesday.