The maker of inhaled insulin Afrezza is betting that relaunching their product and making it a success depends less on diabetics being afraid of needles and more on its clinical advantages over existing insulin.
“There’s more to Afrezza than the needle-phobic aspect of it,” says Michael Castagna, a pharmacist and the Chief Commercial Officer of MannKind, the company that invented Afrezza and recently took over marketing it after drug giant Sanofi dropped the product when it failed to find success. “It’s a completely different, and better way, to lower your blood sugar than [injectable] insulin. In fact, if this was injectable, it would have succeeded on its therapeutic benefits alone.”
MannKind took over control of Afrezza in January 2016 after Sanofi dropped its licensing agreement to market the drug. The move followed not only steep financial losses on the drug for the French drug conglomerate, but also controversy.
Many doctors were reportedly reluctant to prescribe the drug because, even though there wasn’t any proof, they believed long-term use could lead to lung cancer, according to Simon O’Neill, director of health intelligence at Diabetes UK, a nonprofit patient-advocacy group. Then, the FDA insisted Afrezza have a “blackbox” warning label stating that the drug could cause breathing difficulties in patients with respiratory problems; mandated MannKind run a clinical trial on the drug’s cancer risks; and also said doctors had to test every patient’s lung health with a machine called a spirometer before they could prescribe the drug.
Despite this cascade of negative events, MannKind was happy to get the licensing back in their hands. Afrezza, they insisted, failed to achieve blockbuster status because Sanofi did a terrible job marketing the drug. Matthew Pfeffer, MannKind’s CEO, said Sanofi mistakenly focused their marketing on type 2 diabetics who were afraid of needles. He said its clinical benefits to type 1 diabetics were not addressed by Sanofi.
“Being needle phobic is not a good enough reason to change your meds,” Castagne says. “But, the real story is that people have been taking insulin the same way for years and years and this is a completely different, and better drug, than [injectable] insulin. It’s a new paradigm.”
The primary clinical benefit of the fast-acting, inhaled powder over fast-acting insulin, according to Castagna, is that Afrezza works in about five minutes after inhalation. He continued that it also “shuts down hepatic glucose production” so glucose does not first go up then come down, as it can with insulin. In clinical trials results MannKind also claimed that, compared to subjects taking [injectable] insulin, subjects taking Afrezza lost weight while on the drug, and suffered fewer and more moderate hypoglycemic reactions.
The company making the drug isn’t the only one singing its praises.
“I love it, I really do,” says Laura Kronen, a type 1 diabetic for 23 years, who is also the author of a book about diabetes called Too Sweet and a diabetes life coach “I was out one time having Mexican food and margaritas, having a great time. My blood sugar went to 329. Then, I took Afrezza and in 40 minutes it was down to 129. It’s absolutely insane.”
Afrezza comes in four, eight, and twelve unit cartridges, but it’s not directly comparable to taking four, eight, or twelve units of fast acting insulin, Kronen says.
“With insulin and carb counting you have to be an expert in math to be a diabetic,” she says. “With Afrezza I just ask myself whether I’m eating a small dinner or a big dinner, then I decide whether to use a four or an eight unit cartridge.”
Kronen added that she “feels nothing” when she inhales it and that the device is small enough to be used discretely in public so she can deliver the drug undetected.
“I’ve been on it for a year,” she says. “Before I was on it my A1c was 6.8. Now it’s 5.8. Like I said, I love it.”
MannKind recently sent upward of 70 pharmacy reps into the field to educate doctors and patients about the kinds of benefits Kronen is experiencing. And some financial analysts are bullish that MannKind can be successful where Sanofi was not. An article in Forbes by contributor Ken Kam was bluntly headlined, “MannKind Will Market Afrezza Better Than Sanofi Ever Did.”
Despite such praise, even Castagna admits there is a lot to accomplish before Afrezza can be considered a success. Doctors need to be educated, insurance companies need to be more flexible in accepting the drug for reimbursement, and patients need to become comfortable with how Afrezza functions.
“It works best for patients with a continuous glucose monitor so they can see the results,” Castagna says. Additionally, he points out that Afrezza does not replace long-acting insulin, but is used only in the same manner as fast-acting insulin.
For Castagna, the “chaos” of taking on all the various challenges of successfully marketing Afrezza is worth it.
“I was robbed of my father by diabetes,” Castagna says. “I never knew him. I don’t want that to happen to other people. We have a long way to go, and it will take baby steps to get there but, in the end, I want to help people with diabetes do better than they do today.”