MannKind Corporation (NASDAQ: MNKD) has discovered that the US FDA has issued a complete response to United Therapeutics about Tyvaso DPI’s New Drug Application for pulmonary hypertension associated with Interstitial lung disease (PH-ILD) and pulmonary arterial hypertension treatment. As a result, United Therapeutics stock dropped 2.5%, while MannKind shares were down 29.3% premarket.
PAH and PH-ILDs affect lung tissue impacting breathing
PH-ILDs are a collection of diseases that result in scarring and inflammation of the lung tissue, making breathing hard, while and PAH is a high blood pressure that impacts blood vessels in the lungs. The companies started collaborating in the PAH products in 2018, with MannKind manufacturing clinical and commercial supplies and United Therapeutics overseeing regulatory and development activities.
At this point, the FDA has rejected to approve the NDA, citing only one flaw: an open inspection concern at a third-party analytical testing center for treprostinil pharmacological material, Tyvaso DPI’s active ingredient. The FDA cited no concerns with MannKind’s plant in Connecticut for testing, manufacturing, and packing of finished Tyvaso DPI, including its related device, in its comprehensive response.
MannKind CEO Michael Castagna said, “We continue to build pre-launch inventory of Tyvaso DPI and look forward to supporting United Therapeutics’ efforts in securing approval of Tyvaso DPI in the coming months.”
FDA didn’t find any flaws with MannKind’s facility
The FDA did not cite any operational flaws at MannKind’s device manufacturing and testing facility, according to the firms. The inspection focused on a facility that conducts analytical testing of a drug component used in therapy.
According to Reuters, MannKind is sure that the inspection issue will be handled “shortly.” United Therapeutics now plans to introduce the product no later than the summer of 2022.
Tyvaso DPI is a treatment combination that employs United Therapeutics’ approved drug, Tyvaso, with MannKind’s portable inhaler. The Dreamboat device is a tiny and portable dry powder inhaler that makes administration convenient relative to conventional nebulized therapy.
