If you want to experience the emotional rollercoaster that comes with rooting for Afrezza, an inhalable insulin product, look no further than the stock price of Mannkind, Afrezza’s creator. Leading up to a FDA panel review of Afrezza on April 1st, Mannkind shares tanked badly. But once FDA advisors came back with a surprise 13-1 vote in favor of Afrezza for treating T1, the price of Mannkind’s shares shot up 75% in just 4 days.
(The panel also voted unanimously to greenlight Afrezza for treating T2.)
Such a topsy-turvy turn of events doesn’t surprise those who have been following Afrezza’s long, slow road to market. Rarely has a medicine been simultaneously so anticipated and so anticipated to fail. The April 1st meeting was Afrezza’s third time up to the plate with the FDA advisory panel after being twice rejected, and FDA staff had just compiled a report full of skepticism of the inhalable insulin’s ultimate usefulness. It was enough for some biotech investment columnists to preemptively write Mannkind’s obituary.
Instead, with the vote, Afrezza lives to fight another day. It’s not out of the regulatory woods yet, however; the product has only received approval from an advisory panel of scientists, not from the FDA itself. A final decision by the agency could be rendered by April 15th, although procedurally it could come as late as 3 months past that date. It’s always possible the FDA could choose to go against its own advisory panel, but the strong endorsement makes such a prospect unlikely.
So is it time to throw away your needles? Sorry, but no. Even if Afrezza ultimately gets full FDA approval, winning over skeptics in the marketplace may make a day with the FDA feel like a Sunday picnic.
Mannkind has two major challenges to overcome if it’s going to have any large-scale impact on diabetes care. The first is the fact that it really hasn’t outperformed injectable insulin, which leads some to believe that it’s a gimmick product. In a recent study, Afrezza barely held its own against injectable bolus insulin in controlling A1c, and its only claim to performance fame has been that it seems to cut down incidents of hypoglycemia, since it is more fast-acting than subcutaneous insulin. Afrezza’s inability to pull away from the competition could doom it, according to Diabetes Investor David Kliff in a recent column for Forbes.
“Honestly, the data on Afrezza really isn’t all that compelling,” Kliff writes. “About all the drug really had in its favor is the fact that it’s inhaled rather than injected.”
Even more daunting, Afrezza is being overshadowed by the ghost of Exubera, an earlier inhalable insulin that crashed and burned in McWings-like proportions. Marketed by Pfizer in 2006, Exubera was supposed to bring in $2 billion a year in sales. Instead, it was pulled from the market after 13 months because of disappointing sales, and Pfizer ended up taking a $2.8 billion loss on it. Afrezza’s design and performance is better than Exubera’s, but when a product fails that badly it can create a black hole of market perception, where even good products can’t escape.
There is a middle, if unsatisfying, road Afrezza could take between blockbuster and Edsel, that of the niche medicine. FDA panel scientists largely agreed that Afrezza didn’t offer significant improvement over injectable insulin, but it could help with insulin therapy compliance in cases for those who have needle phobias or poor eyesight. Such an argument makes sense; even if Afrezza ultimately performed worse than injectable insulin, it would still be better than no insulin at all, which is what happens for many people with Type 2 diabetes who haven’t warmed to daily injections.
In the end, the FDA panel vote of confidence is like the opening bell for Afrezza. The strong vote in favor will make it easier for Mannkind to line up big-time pharma partners who have the deep pockets needed for a successful rollout. How eagerly investors line up for a chance to invest between now and full FDA approval might be a good indicator of Afrezza’s ultimate fate.
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