With a pediatric approval in hand for Afrezza, MannKind believes that it finally has the boost it needs to make an impact in the market after struggling for more than a decade with the inhaled insulin powder.
On Friday, the FDA signed off on an expansion for Afrezza to treat adolescents and children ages 6 and older with Type 1 or Type 2 diabetes. The drug must be used alongside basal insulin in patients with Type 1 disease, according to a May 29 press release.
The nod comes 12 years after the U.S. regulator cleared Afrezza as a fast-acting, before-meal option for adults with diabetes.
Since reaching the market, Afrezza has generated total sales of roughly $370 million, with revenue peaking last year at $75 million.
“I thought when I got here 10 years ago, Afrezza would have turned around a lot faster,” MannKind CEO Michael Castagna said in an interview with Fierce. “Unfortunately, what I came into was a company that was almost bankrupt, a company that had no financial resources and a data package that wasn’t as solid as I wanted.”
A disastrous commercial partnership with diabetes powerhouse Sanofi didn’t help either, as the French pharma giant bailed on the collaboration a year after launching.
A decade later, MannKind believes it has the data it needs to turn things around. In the phase 3 INHALE-1 study of 230 patients ages 4 to 17, Afrezza provided comparable glycemic control over 26 weeks and was as safe to use as rapid-acting injected insulin. Afrezza also caused less weight gain and received higher scores on patient and parent preference surveys.
“There’s always been a [negative] perception of the safety with inhaled insulin,” Castagna said, adding that lung data from two trials has removed those questions.
MannKind’s job now is to educate endocrinologists, 95% of whom have never prescribed an inhaled insulin, according to the CEO.
“They have no idea how it works, no idea how to prescribe it and the adult community never got behind it,” Castagna said.
By focusing on a subset of physicians who primarily prescribe insulin to adolescents and children, MannKind believes it can drum up more enthusiasm for Afrezza and its key advantage—the immediacy with which it takes effect.
“When you inject in a little bolus in one little part of your body, that insulin takes 45 minutes to break down,” Castagna said. “The key difference here is you take Afrezza when you eat. With injectables, you’ve got to time it 15 minutes before you eat.”
One drawback hindering uptake ties back to patients' need to undergo lung testing with a spirometer, an uncommon piece of physician-office equipment, which determines if a patient has asthma or COPD. Either condition disqualifies patients from using Afrezza.
Afrezza isn’t the first inhaled insulin product to reach the market. In 2006, Pfizer won approval for Exubera, but the product's unwieldy delivery device—which was derisively dubbed the “insulin bong” because of its large tubular design—contributed to its withdrawal from the market in 2007. Afrezza, by contrast, is the size of a whistle.
“Why are we gonna be successful? I think, number one, it’s a limited audience—there’s 1,000 prescribers, there’s 60 centers around the county that make up the majority of patients," Castagna told Fierce. "Number two, social media is going to play a really important role."
The CEO continued, “One of the things that convinced me to take the job pivot 10 years ago was going on YouTube and just typing in Afrezza. I have never seen so many people post positive videos saying, 'I want this drug, it changed my life.'”