Datamonitor: MannKind - FDA's second rejection casts doubt on Afrezza's future

The FDA has requested further Phase III trials of MannKind's inhaled insulin Afrezza with its next generation Dreamboat inhaler before it can be approved. Should it eventually receive approval, Afrezza is likely to attract only a niche patient population, and Datamonitor forecasts that it will garner low sales compared to its competitors, due to safety fears and limited demand for inhaled insulin.

MannKind has announced a further delay for its inhaled insulin product Afrezza (Technosphere insulin), after receiving a second Complete Response Letter (CRL) from the FDA on January 18, 2011.

Afrezza is a powdered form of insulin that patients use with an inhaler, and is targeted at replacing thrice-daily mealtime insulin injections for type 1 and type 2 diabetes patients. It was first submitted to the FDA in March 2009, which responded with its first CRL in March 2010, requiring further data on safety and labeling, as well as information about the proposed MedTone inhaler.

In response, MannKind refiled Afrezza together with a "next generation" inhaler device known as Dreamboat. While the company has shown pharmacoequivalence for the two inhalers, in its January 2011 CRL, the FDA requested further Phase III clinical trials using the Dreamboat inhaler, requiring at least 12 weeks of use in type 1 and type 2 diabetes patients. While MannKind already has Phase III Dreamboat trials underway, it has not included a patient cohort using the older MedTone inhaler, and the FDA has now imposed this further requirement; therefore, the trial design will need to be modified on the basis of further company discussions with the FDA.

Datamonitor expects that trial redesign, completion, and refiling will lead to at least a 12-month delay before Afrezza can be approved in the US. The CRL also leaves doubts hanging over MannKind's hopes for a partnership with a major pharmaceutical company in order to market its inhaled insulin.

In its coverage of the diabetes sector during 2010, Datamonitor had previously forecast a delayed 2012 launch of Afrezza, based on the likelihood of the FDA requiring further studies of the commercial inhaler device. This experience is paralleled by that of Amylin, Eli Lilly, and Alkermes with their antidiabetic Bydureon, which received an FDA CRL in October 2010, requiring, among other things, full results from a Phase III trial using the product's commercial formulation. The 2011 CRL for Afrezza further confirms Datamonitor’s long-term assessment of the diabetes market as providing poor prospects for inhaled insulin agents.

Even if MannKind can gain approval for Afrezza and acquire a major pharma partner to bring it to market, the commercial success of Afrezza is by no means assured. The inhaled insulin sector has continued to over-promise and under-deliver, and significant demand for a non-injectable insulin has yet to materialize in the diabetes market. Furthermore, sales of injected non-insulin glucagon-like peptide-1 (GLP-1) agonists have grown, highlighting the fact that injection is not a barrier to success in the therapy area.

In 2007, the first inhaled insulin product, Pfizer and Nektar Therapeutics' Exubera, was withdrawn from the market, having only launched in 2006. Exubera experienced low uptake due to its bulky and inconvenient inhaler device, and also suffered difficulties in terms of reimbursement, due to the fact that it was a more expensive product, and was perceived as offering no advantage over injected insulins.

In light of Exubera's failure, many physicians believe that the new delivery method alone will not benefit a novel insulin product, and that therapeutic advantages will also be required. However, Afrezza has not been able to show superiority over marketed mealtime insulins in a long clinical trial program, and safety concerns also remain about the effect on patient lung function following chronic, thrice-daily inhaled insulin use.

Datamonitor expects Afrezza to record low sales compared with blockbuster mealtime insulins NovoLog Rapid (insulin aspart; Novo Nordisk) and Humalog (insulin lispro; Eli Lilly). Considering the lingering safety concerns about lung function and the fact that the drug appears to offer no clinical advantage over its competitors, Afrezza is likely to be used only by a niche patient population that strongly resists injectables.

Related Datamonitor Reports:

Datamonitor: Forecast Insight: Asthma/COPD - Pipeline potential outweighs downward pressure from generics:
http://www.reports-research.com/market-surveys/forecast-insight-asthmacopd-pipeline-potential-outweighs-downward-pressure-from-generics-p-127357.html

Datamonitor: Pipeline Insight: Asthma/COPD - Simplified treatments to split the market:
http://www.reports-research.com/market-surveys/pipeline-insight-asthmacopd-simplified-treatments-split-market-p-66428.html

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