Monday, April 25, 2022

United Therapeutics seeks FDA approval of dry powder Tyvaso

United Therapeutics has filed for FDA approval of a dry powder inhalation formulation of treprostinil. The product, Tyvaso DPI, is part of United Therapeutics’ push to double the number of patients on an inhaled form of treprostinil by 2022.

The approval filing covers the use of Tyvaso DPI in pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease. United Therapeutics laid the groundwork for the filing in January, when it revealed a study had demonstrated the safety and tolerability of Tyvaso DPI in patients transitioning from the current inhaled formulation of treprostinil.

Talking to investors in February, Michael Benkowitz, chief operating officer at United Therapeutics, said the company was “preparing to aggressively launch” Tyvaso DPI and make it available to newly diagnosed patients and existing users of its nebulized formulation of treprostinil. Based on physician feedback, Benkowitz is optimistic about the likelihood of a relatively quick transition to Tyvaso DPI. The product is based on MannKind’s Technosphere technology.

United Therapeutics indicated the importance of Tyvaso DPI to its plans by using the voucher it acquired from Y-mAbs Therapeutics for $105 million to shorten the FDA review by four months. The priority review positions United Therapeutics to win approval this year. 

Liquidia Technologies is developing a rival dry powder formulation of treprostinil, LIQ861, but has run into problems. The FDA hit Liquidia with a complete response letter late last year after identifying gaps in the chemistry, manufacturing and controls data on the drug product and device compatibility. 

If Liquidia overcomes the regulatory barrier to market, it could still face other obstacles. United Therapeutics has brought Hatch-Waxman litigation and the U.S. Patent Trial and Appeal Board is reviewing the validity of certain patents. 

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