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MannKind to Submit Afrezza for FDA Approval

Posted: September 24, 2013 5:05 p.m.
Updated: September 24, 2013 5:05 p.m.
 

After years of research and clinical trials, MannKind Corporation of Santa Clarita is less than a month away from finally submitting its innovative diabetes treatment device — Afrezza — to the FDA for approval.

After completing its last round of clinical trials this past spring, the biomedical company released the results in August — pronouncing the results as positive from the Phase 3 clinical study.

“The FDA asked for some very specific things, and we demonstrated those,” said Matthew Pfeffer, corporate vice president and CFO of MannKind.

Using insulin requires a delicate balance of finger-pricking tests, measured doses and timing — making it hard for lay patients to treat themselves adequately.

As a result, doctors will under-prescribe insulin to patients to create a safety margin, Pfeffer said in an interview earlier this spring.

Afrezza, however, gives patients a tool — a device that looks like a whistle — to inhale a rapid-acting insulin therapy involving a dry powder, which allows them to better control insulin levels in their body, he said.

“The FDA wanted us to show the same results as we did before, but with the new device. We needed to show that it was safe,” Pfeffer said.

When injecting insulin, a person must wait 60 to 90 minutes for it to reach peak performance, so people have to predict, more or less, what time they are going to eat — or they could end up in trouble, he said.

Afrezza uses the same form of insulin that the pancreas produces, and by inhaling the dry powder, it can reach peak performance in 12 minutes.

“The lung is a very good mechanism to get things into your system very fast,” Pfeffer said in July. “It gets into the bloodstream quickly and can immediately go to work — similar to what a healthy pancreas does.”

On the backend, injected insulin lingers in the body for too long — up to seven hours. With Afrezza, it’s out of a person’s system within two to three hours, he said.

Referring to diabetes as a pandemic, founder, serial biomed and high-tech entrepreneur Alfred Mann said the need for treatment is so great that he believes Afrezza could “potentially become the most significant medical product ever.”

Mann is such a strong believer in the product that, of the $2 billion invested to date, about $930 million of it has come from his own pockets.

Few CEO’s possess that level of commitment, but that’s his history — if he believes in an innovation, he’ll stick with it and pony up his own money alongside investors. And his track record of success is a huge asset to the company, Pfeffer said.

“We’ll submit to the FDA for approval in October,” Pfeffer said. “We’re as confident as we can possibly be that this will pass through.”

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