FDA approves inhaled insulin
MannKind's long-awaited inhaled insulin product Afrezza has been approved in the US.
The approval on Friday is a triumph for the firm's founder and chief executive Alfred Mann, who has persisted with the drug over nearly eight years despite numerous setbacks, including two previous rejections by the FDA.
Alfred Mann is a billionaire who made his fortune in developing and marketing medical devices, but has found developing a pharmaceutical device more challenging. The company has spent about $1.8 billion bringing the drug to market, and around $975 million of these funds came from Mann's personal wealth.
Afrezza's dry-powder formulation of insulin will compete with mealtime insulins such as Novo Nordisk's NovoLog/NovoRapid (insulin aspart), with which it was compared in phase III trials.
The drug will allow patients to abandon injections for short-acting insulin, but will still have to Afrezza alongside long-acting (basal) insulin treatments such as Sanofi's Lantus.
Despite the FDA approval, many analysts are sceptical about its chances in the highly competitive diabetes market.
Afrezza showed itself to be non-inferior to traditional diabetes treatment in its late-stage trials, but many analysts wonder whether its performance and convenience is enough to persuade doctors and patients to move away from the tried and tested injections.
MannKind's product is not the first inhaled insulin to reach the market – Pfizer's Exubera was launched in 2006, but proved to be a major commercial failure, thanks to a cool reception from doctors and 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 huge 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, with EvaluatePharma generating a consensus forecast of around $600 million a year by 2018, but others believe it can be a runaway, blockbuster success.
Respiratory warning
The drug will carry a boxed warning, highlighting its contraindication in patients with asthma and COPD. This is because acute bronchospasm has been observed in patients with these conditions using the drug. Before initiating use of the drug, doctors must perform a detailed medical history, physical examination and spirometry (FEV1) to identify potential lung disease in all patients.
"Approval of Afrezza is an important milestone for MannKind, as today's FDA action validates the years of clinical research and commitment that powered the development of this unique therapy," said Alfred Mann.
"We are excited for patients, as we believe that Afrezza's' distinct profile and non-injectable administration will address many of their unmet needs for mealtime insulin therapy, and has the potential to change the way that diabetes is treated. We thank the more than 6,500 adult patients and healthy volunteers who participated in the Afrezza clinical programme."
The company has already stated that it plans to pursue approval in Europe. The terms of the FDA approval mean that MannKind must also conduct post-marketing studies to provide further data on its safety and efficacy profile.
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