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UPDATE: FDA approves Valencia firm's inhalable diabetes drug

Posted: June 27, 2014 2:58 p.m.
Updated: June 27, 2014 6:03 p.m.
 

After more than a decade and $2 billion spent in research and development, Valencia-based MannKind Corp. received federal Food and Drug Administration approval Friday for an inhalable diabetes therapy.

The new therapy “has the potential to change the way that diabetes is treated,” said company Chief Executive Officer Alfred Mann.

MannKind’s stock rose 7 percent Friday on news of the FDA’s approval of Afrezza, a fast-acting inhaled insulin therapy that patients can self-administer at the start of a meal, or within 20 minutes after starting a meal.

The therapy includes Afrezza powder delivered via a “small, discreet, easy-to-use inhaler” capable of getting insulin deep into the lungs and into the blood stream within 12 to 15 minutes, a company news release said.

That’s much faster than the typical wait of an hour and a half for traditional injectable insulin, the company and FDA officials said in separate news releases.

In addition, insulin levels return to normal about three hours after inhaling Afrezza, which means there is far less chance of patients having too much insulin in their blood after food is digested.

“We are excited for patients, as we believe that Afrezza’s distinct profile and non-injectable administration will address many of their unmet needs for mealtime insulin therapy and has the potential to change the way that diabetes is treated,” Mann said in a news release

Afrezza’s quick insulin release means people with diabetes, particularly those with type 2 diabetes, the most common form, would be able to go out to a restaurant and simply inhale Afrezza just before eating and not have to worry about their blood sugar levels for the rest of the evening, said Hakan Edstrom, president and COO of MannKind Corp.

“I would say this is a milestone in the treatment of diabetes,” Edstrom said, adding that the Afrezza inhaler is small enough to fit in a person’s palm. “People can inhale it just before they eat and nobody will notice it,” he said.

Dr. Jean-Marc Guettier, director of the FDA’s Division of Metabolism and Endocrinology Products at the agency’s Center for Drug Evaluation and Research, said approval of Afrezza “broadens the options available for delivering mealtime insulin in the overall management of patients with diabetes who require it to control blood sugar levels.”

Afrezza has the potential to revolutionize insulin therapy for the estimated 28.5 million Americans with type 1 and type 2 diabetes, Edstrom said. For people with type 1 diabetes, however, Afrezza must still be used in combination with long-acting, injectable insulin.

“If you are a type 1 patient, you also will need long-working insulin to act between meals, plus Afrezza. People with type 2, they may only need Afrezza, at least during the early stages of the disease,” Edstrom said.

Worldwide, 347 million people have diabetes, a chronic disease that occurs either when the pancreas does not produce enough insulin — a hormone that regulates blood sugar — or when the body cannot effectively use the insulin it produces, according to the World Health Organization’s website.

Type 2 diabetes, which affects about 90 percent of diabetes patients, is largely the result of obesity and lack of exercise, the WHO website says.

In approving Afrezza, the FDA also issued warnings about the therapy’s possible side-effects, including a risk of acute bronchial spasms in patients with chronic lung disease.

In addition, Afrezza should not be taken “during episodes of hypoglycemia, in patients with chronic lung disease such as asthma or chronic obstructive pulmonary disease, or in patients with a hypersensitivity to regular human insulin,” the FDA warning states.

“The most common adverse reactions associated with Afrezza (2 percent or greater incidence) are hypoglycemia, cough, and throat pain or irritation,” the FDA’s news release said.

Edstrom said the company plans to work with major pharmaceutical companies to begin distributing Afrezza commercially during the first quarter of 2015. The product will be produced at MannKind’s facilities in Danbury, Conn., he said.

Depending on the treatment’s success, however, MannKind’s administrative offices in Valencia could see job growth, Edstrom said.

Friday’s federal approval of Afrezza comes more than three years after the FDA asked MannKind to run additional clinical studies on the drug.

But MannKind first began working on the idea of inhalable insulin more than a decade ago, Edstrom said, investing more than $2 billion in getting the therapy approved for sale.

“I would have to say that everyone in the company were all very dedicated to this, and we all feel that we’ve made a major contribution” in treatment options for diabetes patients, said Edstrom.

 

Comments

projalice11: Posted: June 27, 2014 11:42 p.m.

Everyone in the company were all very dedicated to the Afrezza project..
This dedication made a major contribution” in treatment options for diabetes patients..

Yeah to Mannkind Corps..


sherpa: Posted: June 28, 2014 12:09 a.m.

It's been a rough ride but they made it. Made some good money with this stock and hopefully they will continue to make this the blockbuster it should be.



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