In all likelihood, the Afrezza NDA will be approved by the FDA. Whether patients, physicians and payers will support it remains to be seen. But R&D on Afrezza is far from over. While inhaled insulin appears safe for short term use, the FDA will have concerns about the cumulative effect of delivering a growth hormone like insulin to the lung. It is likely that the FDA will require a number of post-marketing studies on Afrezza to support its long-tem use. When the FDA approved Pfizer’s Exubera, it did so on the condition of extensive continuing clinical trials to understand the effects of insulin on the lung. As part of the FDA’s Exubera approval, Pfizer was required to run a number of studies including:
1) A five year large trial in 5,000 diabetics with Type 1 or Type 2 diabetes with 1:1 randomization to either Exubera or usual care. The objectives of this trial were to estimate the relative risk for developing clinically significant decline in lung function as well as the potential clinical risk associated with increases in insulin antibody formation on the potential for developing allergic and immune disorders;
2) A long-term outpatient, open-label, parallel-group comparative trial of the efficacy and safety with Exubera compared with injected insulin therapy in adult Type 1 diabetes over 5 continuous years and 7 cumulative years of Exubera exposure.
3) A long-term, outpatient , open-label, parallel-group comparative trial of the safety and efficacy of Exubera compared with injected insulin in adult Type 2 diabetes over 5 continuous years and 7 cumulative years of Exubera exposure.
In addition, one year studies in Type 1 and Type 2 diabetes patient with asthma and COPD were also required. While one can never predict how the FDA will behave, it is hard to believe that Afrezza won’t be subjected to a similar post-marketing plan.
These types of studies require a great deal of resources costing hundreds of millions of dollars. For a drug with th
Lets take one step at a time... Next step being the FDA's decision and as you said, the Afrezza NDA is likely to be approved by the FDA. Thanks for providing this information but a lot of positive conditions will change for MNKD either prior to approval or shortly after. Either way, regardless of a partnership or a buyout Afrezza will be a multi-billion dollar drug. Annual multi-billion dollars minus (maybe) a few hundred million. You do the math! I gotta get back to my one step at a time approach but I'll check back after the next step is complete whether it be FDA approval, partnership or buyout.
The "former Pfizer Head of Exubra development Project" is a loser and a paid basher by Hedge funds. Think about it. Why will that loser who ended up dumping his whole life worth of work, bash other much better product. The loser is selling his designation for a few hundred thousand bucks. Probably he had shorted also before posting. If that guy was very intelligent, he would not have been the superisor of a failure.