From the article
Insulin (Exubera® and Afrezza®)
Insulin is one of many pharmaceutical agents to maintain glycemic control for diabetic patients. Diabetes is considered one of the fastest-growing disease entities in the United States, encompassing 23.6 million people (17.9 million diagnosed and 5.7 million undiagnosed) who represent 7.8% of the US population.13 Subcutaneous insulin injections and various classes of oral antidiabetic agents have been the two primary delivery methods for treatment of hyperglycemia in type 1 and type 2 diabetes mellitus. New advances in aerosol delivery have developed inhaled formulations to assist in glycemic control and to provide another therapeutic delivery method for patients. In February 2006, Pfizer Pharmaceuticals (Collegeville, Pa) in conjunction with Nektar Therapeutics (San Carlos, Calif) received FDA approval for their inhaled insulin product Exubera.14 Exubera was considered to be a potential blockbuster drug, with projections of US sales greater than $1 billion. Unfortunately, approximately 2 years after approval and dismal sales, Pfizer withdrew Exubera from the US market. Although the drug demonstrated efficacy in assisting in glycemic control, withdrawal was based on a number of factors, including patients requiring periodic pulmonary function testing due to potential pulmonary complications of the inhaled product, cumbersome apparatus that was not designed for portable transport, concern over lung cancer associated with its use, and losing US$2.8 billion in development costs.14-15 Although removal of Exubera was a major setback for the use of inhaled insulin, there is hope for another inhaled insulin product.
MannKind Pharmaceuticals (Valencia, Calif) completed phase 3 trials in 2009 and submitted a new drug application (NDA) to the FDA in May 2009 for the drug Afrezza (insulin human [rDNA origin]) inhalation powder.15 Insulin human (rDNA origin) is indicated for use in adult patients with type 1 and type 2 diabetes mellitus for the treatment of hyperglycemia. The drug was headed for FDA approval, when, in March 2010, the FDA asked for more information on the phase 3 trial as well as the delivery device.16 This agent has many advantages of Exubera, including a premetered, light, discreet delivery device. Further, peak insulin levels are achieved within 12 to 14 minutes after administration. Some experts estimate that insulin human (rDNA origin) will receive FDA approval in early 2011.
MannKind failed to win US approval for its first product, Afrezza (insulin human [rDNA origin]), an inhaled insulin for diabetes. The FDA wants the company to do two new studies of the device in patients with Type 1 and Type 2 diabetes. This action will delay the drug from coming on the market by 18 to 24 months, according to CEO Alfred Mann.