Why did the FDA give a CRL to Mannkind?
The FDA is responsible for approving drugs that can improve the health and quality of life of the American public (safety & efficacy). When they approve drugs that go on to do exactly that, no one things about them at all. On the other hand, if they approve a drug that ends up doing more harm than good, than they get beat up by the public & the media.
With this background, think about Mannkind's case. They submitted one of the most detailed NDA applications in the history of the FDA to the FDA for a drug that targets one of the most prevalent diseases in the US (diabetes). Drugs which target small groups of patients or patients for which other drugs do not work will receive less scrutiny simply because the possibility of harm in the sense of number of people harmed by the drug will be fewer and the likelihood of discovering this harm is also smaller since the sample size of patients is smaller. In the case of diabetes, the patient sample size will be huge especially since Afrezza stands to revolutionize the treatment of this disease. If something were to go wrong, it would be quicker in surfacing and the number of people impacted would be large (due to the large patient population).
Al Mann and the management team probably recognized this which is why they had such a large and detailed filing the first time around. However, in the hopes of getting the new Gen2 inhaler to market quicker, they forgot this aspect when they submitted their response to the CRL to the FDA.
The FDA response during the meeting (for which no minutes were ever published) was probably that of outrage. Mannkind had submitted responses using a different inhaler than the one used to generate all the data that they had studied for over a year. Mannkind executives probably tried to explain that the new inhaler was bio-equivalent (ie the same amount of drug went into the body with both inhalers), the risk-averse FDA officials didn't buy the story. Hence, we got the CRL a few weeks ago asking for clinical trials of the new inhaler.
That being said, they did buy into the Afrezza story...there are no more doubts about that in the CRL...just the delivery device.
The FDA is responsible for approving drugs that can improve the health and quality of life of the American public (safety & efficacy). When they approve drugs that go on to do exactly that, no one things about them at all. On the other hand, if they approve a drug that ends up doing more harm than good, than they get beat up by the public & the media.
With this background, think about Mannkind's case. They submitted one of the most detailed NDA applications in the history of the FDA to the FDA for a drug that targets one of the most prevalent diseases in the US (diabetes). Drugs which target small groups of patients or patients for which other drugs do not work will receive less scrutiny simply because the possibility of harm in the sense of number of people harmed by the drug will be fewer and the likelihood of discovering this harm is also smaller since the sample size of patients is smaller. In the case of diabetes, the patient sample size will be huge especially since Afrezza stands to revolutionize the treatment of this disease. If something were to go wrong, it would be quicker in surfacing and the number of people impacted would be large (due to the large patient population).
Al Mann and the management team probably recognized this which is why they had such a large and detailed filing the first time around. However, in the hopes of getting the new Gen2 inhaler to market quicker, they forgot this aspect when they submitted their response to the CRL to the FDA.
The FDA response during the meeting (for which no minutes were ever published) was probably that of outrage. Mannkind had submitted responses using a different inhaler than the one used to generate all the data that they had studied for over a year. Mannkind executives probably tried to explain that the new inhaler was bio-equivalent (ie the same amount of drug went into the body with both inhalers), the risk-averse FDA officials didn't buy the story. Hence, we got the CRL a few weeks ago asking for clinical trials of the new inhaler.
That being said, they did buy into the Afrezza story...there are no more doubts about that in the CRL...just the delivery device.
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