In a key regulatory development, MannKind Corp. of Westlake Village on Wednesday announced that its application for approval of an inhalable drug has been accepted for priority review by the Food and Drug Administration.What’s more, the FDA indicated that there are no potential review issues at the moment, according to a statement from MannKind and its partner in the venture, United Therapeutics Corp. of Silver Spring, Md.MannKind is known for developing an inhalable insulin for diabetics. The new inhalable drug, called Tyvaso DPI, is used to treat pulmonary arterial hypertension, a condition in which the arteries connecting the heart to the lungs become increasingly narrower, resulting in high blood pressure.Tyvaso DPI uses the same inhaler technology found in Afrezza, MannKind’s inhalable insulin.
MannKind’s system, called Technosphere, delivers drugs quickly with small inhalers. Wednesday’s announcement solidifies the promise of the system to work with drugs other than insulin.MannKind’s chief executive, Michael Castagna, said in a statement that, “With this key regulatory step, we are excited to progress the next Technosphere product” towards use by those with pulmonary arterial hypertension and similar afflictions.Pulmonary hypertension is a form of high blood pressure that scars and inflames arteries in the heart and lungs.MannKind and United Therapeutics are also developing a Bluetooth accessory for the Tyvaso DPI inhaler called BluHale. The Bluetooth accessory uses a companion mobile app to monitor information about patients’ inhaler use.MannKind said in a statement that the approval process will include an inspection of the MannKind-operated Tyvaso DPI manufacturing facility. The FDA and MannKind targeted the inspection’s completion for the third quarter.Shares of MannKind (MNKD) went up 23 cents, or 5.6 percent, to close at $4.33 on the Nasdaq on Wednesday, a day when that market declined a fraction of a percent.
FDA to Give ‘Priority Review’ to MannKind’s New Drug
