Inhaled insulin recommended by FDA committee


An FDA committee has given an overwhelming recommendation to new inhaled insulin treatment Afrezza.

MannKind Corporation has spent years and many millions of dollars in developing the novel formulation, and has seen Afrezza rejected on two previous occasions.

But it now looks like third time lucky for MannKind, which looks set for approval after the FDA's endocrinologic and metabolic drugs advisory committee backed the drug's safety and efficacy.

The promise of the inhaled insulin is to free diabetes patients from injecting themselves, but doubts about safety and efficacy have dogged Afrezza and other similar inhaled insulin candidates until now.

The committee voted 13 to 1 to recommend Afrezza (insulin human [rDNA origin]) inhalation powder be approved for adults with type 1 diabetes, and voted 14 to 0 to recommend approval for adults with type 2 diabetes.

"We are pleased with the Advisory Committee's approval recommendation in support of Afrezza, and we appreciate the thoroughness of their review," said Alfred Mann, chairman and chief executive of MannKind. "We look forward to working with the FDA as they complete their evaluation of Afrezza. Diabetes is a major health problem in the United States, and we are committed to bring Afrezza to the many patients who might benefit from this novel product."

The FDA is not bound by the advisory committee's recommendation but will consider its guidance and issue its response by 15 April.

Doubts about commercial prospects

Despite the FDA committee's recommendation, there remains considerable scepticism about the drug's commercial potential.

The nature of the inhaled insulin means it is competing with other short-acting meal time (bolus) insulins – it cannot challenge long-acting (basal) insulin treatments such as Sanofi's Lantus.

MannKind believe that Afrezza's dry-powder formulation of insulin can contend with Novo Nordisk's NovoLog/NovoRapid (insulin aspart) which it was compared to it in its phase III trials.

While MannKind's drug proved non-inferior to traditional diabetes treatment in its late-stage trials, many analysts wonder whether its performance and convenience is enough to persuade doctors and patients to move away from the tried and tested injections.

Analysts point to the commercial failure of the only other inhaled insulin to reach the market – Pfizer's Exubera. The drug was launched in 2006, but was not popular with doctors or patients. MannKind points out that its inhaler device is far smaller and convenient that the Exubera device, and is confident it will not face the same problems. Some commentators believe the drug has blockbuster potential, believing its inhaled formulation will bypass the reluctance of patients to take injections, which frequently delays insulin initiation.

Peak sales forecasts for the drug vary considerably, and EvaluatePharma estimates the consensus at around $600 million a year by 2018.


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2 April, 2014