U.S. FDA declines to approve United-Mannkind’s lung disease therapy By Reuters

© Reuters. FILE PHOTO: Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly

(Reuters) – The U.S. Food and Drug Administration declined to approve United Therapeutics (NASDAQ:) and Mannkind Corp’s lung disease therapy, citing an inspection issue at a third-party facility, the companies said on Monday.

The therapy is a drug-device combination that uses United Therapeutics’ approved treatment, Tyvaso, in combination with MannKind (NASDAQ:)’s portable inhaler.

MannKind’s Dreamboat device is a small and portable dry powder inhaler, making its administration more convenient than the traditional nebulized therapy. [Pn2cP6yja]

MannKind’s shares fell nearly 28% to $3.68 in premarket trading.

The companies said the agency did not cite any operational shortcomings at MannKind’s device manufacturing and testing facility. The inspection was related to a facility that performs analytical testing of drug substance used in the therapy.

The companies were seeking approval of Tyvaso DPI to treat patients with pulmonary arterial hypertension (PAH), as well as PAH associated with interstitial lung disease.

While PAH is a type of high blood pressure that affects blood vessels in the lungs, PH-ILDs are a group of diseases that cause inflammation and scarring of the lung tissue, making it harder to breathe.

United recorded $153.8 million in second quarter sales of Tyvaso.

MannKind and United Therapeutics began collaborating on the pulmonary hypertension product in September 2018. MannKind manufactures the clinical and commercial supplies, while United is responsible for development and regulatory activities.

United said it now expects to launch the product no later than summer of 2022.

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