MannKind Corporation (NASDAQ: MNKD) jumped 5.61% following the achievement of a significant milestone with United Therapeutics Corporation (NASDAQ: UTHR), which gained 2.8%, regarding Tyvaso DPI for pulmonary hypertension-related with interstitial lung disease and pulmonary arterial hypertension treatment. The companies announced that the US FDA had accepted a priority review for its NDA for Tyvaso DPI.
FDA reviewing Tyvaso IDP NDA
The FDA is currently reviewing the development of the second drug made utilizing MannKind’s Technosphere® technology, expected to be completed in October 2021. According to the FDA, there are no possible review concerns detected for now.
Martine Rothblatt, the United Therapeutics CEO, said that the NDA review acceptance for Tyvaso DPI is a significant regulatory milestone towards delivering the new treatment for PH-ILD and PAH patients. Rothblatt said that once Tyvaso DPI gets approval, it will enable the company to achieve its goal of serving over 25,000 patients by the end of 2025.
Tyvaso uses same tech Afrezza
Tyvaso DPI is a next-generation treprostinil formulation that uses the same dry powder formulation technology and Dreamboat® inhalation device technology as MannKind’s Afrezza® (insulin human) Inhalation Powder, which received FDA approval in 2014. In comparison to standard nebulized Tyvaso therapy, Tyvaso DPI is projected to offer a more efficient mode of delivery if approved. The companies are also working on BluHale®, a mobile application Bluetooth-connected accessory for the Tyvaso DPI inhaler, to help patients track information about their inhaler use.
MannKind Corporation CEO Michael Castagna said that they are delighted with Tyvaso DPI NDA acceptance for priority review. He said that the company is driven to bring therapeutics that can help enhance patients’ lives. With this vital regulatory step, Castagna is delighted to move the following Technosphere products toward offering PH-ILD and PAH patients a convenient treprostinil therapy delivery mode.