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

by Mike Robinson

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© Reuters. FILEPHOTO: This sign can be seen at White Oak headquarters of Food and Drug Administration in Maryland on August 29, 2020. REUTERS/Andrew Kelly

(Reuters) – The U.S. Food and Drug Administration has declined to approve United Therapeutics’ (NASDAQ:) lung disease treatment. Mannkind Corp cited an inspection problem at a third party facility as the reason, according to Mannkind Corp on Monday.

This therapy combines United Therapeutics’ Tyvaso approved treatment with MannKind’s (NASDAQ:) portable inhaler.

MannKind’s Dreamboat inhaler is small, portable and easy to use. [Pn2cP6yja]

MannKind lost nearly 28% on pre-market trading to reach $3.68

According to the companies, MannKind did not mention any operational problems at MannKind’s device manufacturing or testing plant. Inspection was conducted at a facility which analyzes the drug substance that is used in the therapy.

These companies sought approval for Tyvaso DPI in order to treat patients suffering from pulmonary arterial hypertension (PAH) and interstitial lung diseases.

While PAH can be described as a high blood pressure condition that damages the blood vessels within the lungs (blood vessels), PHILDs refer to a variety of lung diseases that create inflammation and scarring that makes it more difficult for the lungs to function properly.

Tyvaso sales for the second quarter of 2012 were $153.8 million.

MannKind started working with United Therapeutics on the pulmonary Hypertension product in September 2018. MannKind makes the supplies for clinical use and commercial purposes, and United does development and regulatory work.

United indicated that the company expects to release the product by summer 2022.

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