MannKind's inhaler insulin Afrezza gained F.D.A. approval, Friday, June 27.
Andrew Pollack of the New York Times offers a lot of good news for insulin-dependent diabetics in "Afrezza, a New Inhaled Insulin, Is Approved by the F.D.A."
Fast-acting Afrezza is the size of a referee whistle, making it more convenient to carry around than traditionally bottled insulin or the pens. For diabetics having to carry insulin in order to survive, it'll be helpful.
And unlike Pfizer's Exubera, there's a chance of success. Exubera was the size of a tennis ball, so transporting medication was impossible, and that’s vital for insulin-dependent patients.
As a Type 1 diabetic, I'm hoping Afrezza sticks around. This year was my 10th anniversary and I've gone from bottles to pens, noticing how nice it's been to carry my medication. I don’t qualify for an insulin pump, so right now these are my options.
Of course, price is always an issue. When I was using bottled Lantus in 2011, the price averaged about $120 per vial. And Humalog, my other medication, was $140. And that was without insurance. If you have to take several of each a month, it adds up.
Not to mention the exclusivity of design means MannKind can determine market price. Many diabetics will see the importance and relevance, so more people will be interested in test-running the medication. That means cash-in-hand as the nation jumps on board to President Obama’s Affordable Healthcare Act.
There's also the cost of development and recouping the $2.3 billion already spent. And Mann himself has put in $900 million of his own money "but his roughly 40 percent stake in the company is worth around $1.6 billion.”
Alfred E. Mann, MannKind's chief executive, has personally invested that money in order to produce a viable delivery method.
The 88-year-old billionaire seemed very content at the news. "Today’s F.D.A. action validates the years of clinical research and commitment that powered the development of this unique therapy." And Mann has experience in the diabetic field after creating MiniMed, an insulin pump business, which sold to Medtronic for $3 billion dollars.
However, the F.D.A. did insist on more tests due to safety concerns by doctors. If a patient has any sort of breathing hindrance like asthma, COPD, or recently smoked, Afrezza won’t help them.
Questionable use involves Afrezza’s mealtime injection replacement for Type 1 diabetics, who are insulin-dependent and have limited options of delivery and medication. However, reports demonstrated “Afrezza provided less reduction in blood sugar than injected insulin, but the results were close enough that trial was deemed a success.”
UPDATE 3-Eli Lilly copy of $8 bln Sanofi insulin wins EU green light - Reuters http://t.co/viWQR4AVsU— US Health News (@USHealthNews) June 27, 2014
Without a huge corporate backer, MannKind faces distribution struggles, according to Chief Financial Officer Matthew J. Pfeffer. Pollack notes the CFO added “that Afrezza would not be available to patients until a partner was ready.”
Right now, the U.S. pharmaceutical corporations are buying each other out, or attempting to merge into a much stronger, but more homogenous business market.
In the United States, insulin is big business because it's harder to buy generic medication. Yet in Europe, generic insulin is gaining ground. Recently Eli Lilly, Humalog maker, won a European case for creating a generic version of Lantus when the patent runs out May 2015.
While it took two times to okay MannKind’s Afrezza, availability seems a lot closer at hand.
Hopefully, the medicine will be on the market soon since the9.1% of the U.S. population are diabetics—that’s 29.1 million known patients. And the numbers only climb year-to-year. More options are better for patients.