MannKind Corporation (NASDAQ:MNKD) Announces Tentative Date For Afrezza Review
MannKind Corporation (NASDAQ:MNKD), a development-stage biopharmaceutical company focussed on the development of therapies for diseases such as diabetes and cancer, saw its shares sanking as much as 17% last week soon after it announced a tentative date for the review of its inhaled diabetes medication, Afrezza, by the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA).
On Friday, the company said the FDA had tentatively scheduled a review of AFREZZA on April 1, 2014 to review MannKind’s New Drug Application (NDA) for AFREZZA. However, the target date for the FDA to complete its review of Afrezza New Drug Application (NDA) is April 15, 2014.
On October 13, 2013, the company re-submitted the NDA seeking market approval for its insulin human inhalation powder in the United States. The drug is said to improve glycemic control in adults with type 1 or 2 diabetes.
AFREZZA is insulin that is in late-stage clinical investigation for the treatment of diabetes for the control of hyperglycaemia. The inhalation powder is centred on a class of potential of hydrogen (pH)-sensitive organic molecules and uses its Techno sphere formulation technology.
According to MannKind, the 2-year pulmonary safety study in adult patients suffering from Type 1 and Type 2 diabetes proved that changes in pulmonary function tests associated with Afrezza were comparable to the changes seen in patients, who were treated using usual care, including insulin or oral therapies. “The most common adverse events reported during Afrezza clinical trials were hypoglycaemia and mild, transient, non-productive cough,” the company said.
With a positive clinical data, MannKind is now hoping that its completely redesigned inhaler will bring in a different outcome. Afrezza, if approved, is expected to become a strong player in the $44 billion insulin market.
MannKind is hoping for a positive outcome and believe that Afrezza would be able to satisfy diabetes patients’ need. To date, the clinical program of Afrezza has involved 56 different studies and more than 5,300 patients. By offering significant benefits to the growing population of diabetic patients, the company believes that its inhalation powder has the potential to change diabetes therapy.