Drugs

United Therapeutics Snubbed on Tyvaso DPI

FDA has issued United Therapeutics a complete response letter on its NDA for Tyvaso DPI (treprostinil) for treating pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease to improve exercise capacity. FDA’s letter, according to the company, cited a deficiency related to an open inspection issue at a third-party facility that performs analytical testing of the drug substance. United Therapeutics also noted that there were no deficiencies cited at partner MannKind’s manufacture, testing, and packaging of finished Tyvaso DPI, including its associated device.

“We are confident that the single deficiency identified in the complete response will be resolved quickly and that Tyvaso DPI can receive approval by the summer of 2022, if not earlier,” the company says.

Additionally, the letter says the agency has not yet completed its review of a citizen petition submitted by Lassman Law+Policy on behalf of an unnamed client in July concerning the safety of an excipient in Tyvaso DPI. The petition says specific additional testing is necessary because a primary component of the Tyvaso formulation is fumaryl diketopiperazine, a novel excipient previously approved for use only in Mannkind’s Afrezza (insulin recombinant human) inhalation powder. “Afrezza, however, poses a serious risk of acute bronchospasm in patients with chronic lung disease, such as asthma and chronic obstructive pulmonary disease,” the petition says (see earier story).

The NDA submission includes data from the BREEZE clinical study that demonstrated safety and tolerability of Tyvaso DPI in patients with PAH transitioning from Tyvaso Inhalation Solution. “A separate study in healthy volunteers demonstrated comparable treprostinil exposure between Tyvaso DPI and Tyvaso Inhalation Solution,” United Therapeutics says.

The product was formulated with MannKind’s dry powder formulation technology and Dreamboat inhalation device technology used in MannKind’s Afrezza (insulin human) Inhalation Powder, which was approved in 2014. The companies say they are also developing BluHale, a Bluetooth-connected accessory for the Tyvaso DPI inhaler with a companion mobile application intended to help patients track information about their inhaler use.

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