FDA approves Inhalable Insulin – Afrezza

  • A non injectable form of Insulin is not widely available in the market till now.
  • The research on a inhalable insulin product was undergoing for a long time.
  • This form of Insulin once available in market widely will decrease the difficulties caused by daily injections and some times multiple daily injections to the patients of Type 1 DM. This will also increase the compliance and general acceptability of Insulin as a whole by the patients who needs short and fast acting insulin.


The Food and Drug Administration (FDA) approved a long-delayed inhalable diabetes medication to help patients control their blood sugar levels during meals.

The FDA cleared MannKind Corp.’s Afrezza, a fast-acting form of insulin, for adults with the most common form of diabetes.

The approval decision comes more than three years after the agency first asked MannKind to run additional clinical studies on the drug.

Inhaler: The device, which is about the size of a referee’s whistle, could replace injectable insulin

Tiny: Other, similar devices have been much larger – some the size of a tennis ball – than the Afrezza device

Afrezza Device

Approval for the drug is a milestone for MannKind Corp., and its billionaire chief executive, 88-year-old Alfred E. Mann, who has devoted much of his fortune to developing the revolutionary delivery system for the in-demand drug.

‘Today’s F.D.A. action validates the years of clinical research and commitment that powered the development of this unique therapy,’ Mann said in a statement to the New York Times.

Demand for diabetes treatments is surging globally as the prevalence of obesity explodes.

According to the World Health Organization, roughly 347 million people worldwide have the disease, a chronic condition in which the body either does not make enough insulin to break down the sugar in foods or uses insulin inefficiently. It can lead to blindness, strokes, heart disease or death. In type 2 diabetes, the most common form of the disease, the body does not use insulin properly.

Type 1 diabetes is usually diagnosed in children and young adults. In those cases, the body does not produce insulin.

Afrezza, an insulin powder, comes in a single-use cartridge and is designed to be inhaled at the start of a meal or within 20 minutes. MannKind has said that patients using the drug can achieve peak insulin levels within 12 to 15 minutes. That compares to a wait time of an hour and a half or more after patients inject insulin.

 The FDA said in its approval announcement that Afrezza is not a substitute for long-acting insulin and is a new option for controlling insulin levels during meals.

The agency approved Afrezza with a boxed warning — the strongest type — indicating that the drug should not be used in patients with chronic lung diseases, such as asthma and smoker’s cough, due to reports of breathing spasms.

 The agency is also requiring several follow-up studies looking at the drug’s long-term safety, including its impact on the heart and lungs.

Mannkind first submitted the drug to FDA in March 2009. The Valencia, California-based company has no other products on the market and lost more than $191 million last year.

 MnnKind Corp: MannKind Corp.’s lone product is Afrezza, which it has devoted hundreds of millions of dollars into developing

Several other companies have failed to make inhaled insulin work commercially. In 2007, Pfizer Inc. discontinued its inhaled insulin Exubera after it failed to gain ground on the market. In 2008, Eli Lilly & Co. ended its development program, citing regulatory uncertainty.

Source: DailyMail

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