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US FDA Rejects Lung Disease Therapy of MannKind and United Therapeutics

The US FDA has rejected a lung disease therapy, which was developed by the United Therapeutics and the MannKind Corp, which has been citing an inspection issue at the third-party facility in the United States.

On Monday, 18th October 2021, the draft label of the healthcare regulator for the drug, known as Tyvaso DPI, that has been including the use of the drug as a treatment for the pulmonary arterial hypertension (PAH), along with the PAH that has been associated with the interstitial lung disease (PH-ILD).

In the response letter, the US FDA does not cite any of the deficiencies that has been related to the operations at the device manufacturing and testing facility for the Tyvaso DPI of MannKind, while the PAH has been a type of the high blood pressure that is responsible for affecting the blood vessels in the lungs.

The PH-ILD has been a group of the several diseases that are responsible for causing the inflammation along with scarring of the lung tissue, which is responsible for making it harder to breathe.

Both the companies including United Therapeutics and MannKind has started collaborating on the product of the pulmonary hypertension in the month of September 2018, and the company ‘MannKind’ generally manufactures the commercial and the clinical supplies, while the United Therapeutics has been responsible for the development and the regulatory activities in the United States. United Therapeutics said, the company is now expecting to launch the product by the summer of 2022.