FDA is concerned with Afrezzza’s potential safety issues that could be attached with insulin inhalation., namely cancer risks that could be associated with Afrezza.
(Yuck...Imagine cancer of the nose...You just know some ignorant parents will see this as an easy way out to deal with their own evil in feeding their children Monsanto trash, and creating diabetes in their kids...)
The Adcom recommended a post approval safety trial, but for reasons I will mention below, it’s more likely pre clinical data will be required since it appears Mannkind has offered no pre clinical studies on potential cancer risks. In fact, when considering Mannkind’s constant mis guidance and misleading activities for which they have been successfully sued over in the past, we believe Mannkind does not have this data. This presents a huge potential problem for the FDA, and something the adcom ignored, much as another adcom (see below) ignored solid data when rejecting to recommend a certain drug (Zohydro) for approval, of which the FDA went against and rightly approved the drug anyways.
In other words, while adcom might think it’s approvable now, I believe the FDA will not follow adcom here as it did not follow on the Zohydro adcom. (more on that later on)
Additionally, I believe the FDA does not want another Exubera type issue on its’ hands In this regard, Mannkind has seemed to ignore the FDA two times now, which is very typical of this company — to have an aloof attitude towards the FDA.In the Type 1 diabetes study, insulin levels were significantly higher in the Afrezza arm compared to the control arm. The FDA raised concerns here about the background basal insulin levels that were significantly higher in the Afrezza arm compared to the control arm.
In the Type 2 study, the FDA said that Afrezza was superior to placebo for the primary endpoint of HbA1c reduction, but it also pointed out comparative effectiveness data showing how Afrezza was inferior to just about all currently available type 2 diabetes therapies.
The Adcom recommended a post approval safety trial, but for reasons I will mention below, it’s more likely pre clinical data will be required since it appears Mannkind has offered no pre clinical studies on potential cancer risks. In fact, when considering Mannkind’s constant mis guidance and misleading activities for which they have been successfully sued over in the past, we believe Mannkind does not have this data. This presents a huge potential problem for the FDA, and something the adcom ignored, much as another adcom (see below) ignored solid data when rejecting to recommend a certain drug (Zohydro) for approval, of which the FDA went against and rightly approved the drug anyways.
In other words, while adcom might think it’s approvable now, I believe the FDA will not follow adcom here as it did not follow on the Zohydro adcom. (more on that later on)
Additionally, I believe the FDA does not want another Exubera type issue on its’ hands In this regard, Mannkind has seemed to ignore the FDA two times now, which is very typical of this company — to have an aloof attitude towards the FDA.In the Type 1 diabetes study, insulin levels were significantly higher in the Afrezza arm compared to the control arm. The FDA raised concerns here about the background basal insulin levels that were significantly higher in the Afrezza arm compared to the control arm.
In the Type 2 study, the FDA said that Afrezza was superior to placebo for the primary endpoint of HbA1c reduction, but it also pointed out comparative effectiveness data showing how Afrezza was inferior to just about all currently available type 2 diabetes therapies.
The above factor goes in part to show that Afrezza is not quite an unmet need, but rather an “unmet want” as there are equal and superior treatments for diabetics on the market now. Afrezza can be considered a very small unmet need for patients who simply cannot receive injectable insulin. When I think of a true unmet need, I think of Acadia’s (ACAD) Pimavanserin.
Even if it’s approved, no big pharma will partner with Mannkind for Afrezza. The best Mannkind can hope for royalty deal, and that is my independent opinion. My sources tell me the same thing. Simply stated, Afrezza does not have the blockbuster potential that its’ management (with its’ history of misleading statements) and its’ “Jim Jones” like cult followers claim and believe."
FDA APPROVED IT! Last week...
"FDA Approval Comes Finally…
After being rejected twice by FDA, MannKind Corp. (MNKD) has finally won approval to sell Afrezza, a novel rapid-acting inhaled insulin for the treatment of adults with diabetes mellitus.
Afrezza will sport a Boxed Warning, and according to reports, it is expected to be launched in the first quarter of 2015.
\MannKind focused its efforts solely on developing Afrezza since going public in 2004, and it has reportedly cost the company $1.8 billion.
The FDA has asked the company to conduct the following post-marketing studies for Afrezza:
-- a clinical trial to evaluate pharmacokinetics, safety and efficacy in pediatric patients
-- a clinical trial to evaluate the potential risk of pulmonary malignancy with Afrezza (this trial will also assess cardiovascular risk and the long-term effect of Afrezza on pulmonary function)
-- two pharmacokinetic-pharmacodynamic euglycemic glucose-clamp clinical trials, one to characterize dose-response and one to characterize within-subject variability."
"FDA Approval Comes Finally…
After being rejected twice by FDA, MannKind Corp. (MNKD) has finally won approval to sell Afrezza, a novel rapid-acting inhaled insulin for the treatment of adults with diabetes mellitus.
Afrezza will sport a Boxed Warning, and according to reports, it is expected to be launched in the first quarter of 2015.
\MannKind focused its efforts solely on developing Afrezza since going public in 2004, and it has reportedly cost the company $1.8 billion.
The FDA has asked the company to conduct the following post-marketing studies for Afrezza:
-- a clinical trial to evaluate pharmacokinetics, safety and efficacy in pediatric patients
-- a clinical trial to evaluate the potential risk of pulmonary malignancy with Afrezza (this trial will also assess cardiovascular risk and the long-term effect of Afrezza on pulmonary function)
-- two pharmacokinetic-pharmacodynamic euglycemic glucose-clamp clinical trials, one to characterize dose-response and one to characterize within-subject variability."
Go to the FDA if you want to know more...
Some of our concerns with Afrezza are: lung safety issues, dropout rates, missing data, and lower efficacy when compared to subcutaneous insulin. Additionally, some believe that if the missing data and/or dropout data were included, the Phase III efficacy would have failed. The dropout rate for Afrezza was higher than Novolog and many patients dropped out due to the lack of efficacy.
That's how it works ...at FDA
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