|
Bald steht die Entscheidung an ob das zu inhalierende Insulin von Mannkind von der FDA zugelassen wird und aufgrund der nadelfreien Anwendung könnte es ein Game-Chancer werden: Mannkind ...Afrezza approval is a good bet 15 comments Jan 7, 2011 5:19 PM | about stocks: MNKD Font: PrintEmail Recommend 2 Share this page Share0 Mannkind is a pharmaceutical company with one product close to approval, Afrezza, an inhaled insulin. In my opinion, Afrezza will be approved around January 21, 2011. The FDA is concerned with safety, efficacy, and clinical need. 1) Let's examine efficacy first. In several major trials spanning thousands of patients and almost a decade, Afrezza has shown that HBA1C, i.e. blood glucose level over an average period of time, was as good as rapid acting injected insulin, i.e. lispro. Primary end points of all of these trials were met. Importantly, all of the secondary end points were also met. Afrezza usage was characterized by substantially fewer hypoglycemic events, lower post prandial glucose (PPG), lower fasting blood glucose (FBG), and less weight gain and even weight loss. A recent study also shows that Afrezza works in a different way than lispro such that Afrezza is safer because efficacy is maintained without hypoglycemia regardless of carbohydrate intake at meal time. This will require more study; but it is important. 2) Now let's examine safety. Does Afrezza result in significantly lower lung function over time? Four years of trial data show that the old inhaler resulted in lower lung function than the control group, but that this lower lung function was not statistically significant. Recent data submitted to the FDA shows that the new inhaler actually results in no lung function difference; however, the trial was very short term. More studies will be need to show this. Either way, the trial end points were met. The second question is does Afrezza cause tumors and is there residual insulin buildup in the lungs? Two studies (106 and 52 week rat and mouse studies) and patient CT scans revealed no tumor or carcinogenic effect or surfactant action or insulin buildup. Finally, does Afrezza adversely impact cardio function? QT trial data showed that Afrezza causes no QT delay. 3) Patient need? One of the biggest issues with injected insulin is patient compliance. There are several issues. Many patients have difficulty with the rigors of carb counting, injection and glucose monitoring. The bottom line is that patients who take Afrezza will tend to remain more compliant because all of these are less difficult while using Afrezza. That's a big big, really really good thing in the diabetes world. Furthermore, because injected insulin peaks too late after meal time and remains in the system at higher levels than needed long after the meal is digested, patients are prone to hypoglycemia. Afrezza solves this problem by peaking early during the meal and moving out of the system after three hours. 4) In March 2010, Mannkind received a CRL in which the FDA asked for clarification as to how Afrezza fits into the armamentarium of diabetes treatment. The FDA asked that the bioequivalency trial data comparing inhalers be resubmitted ina new format. The FDA also asked for certain packaging label clarification. The FDA did not ask for new efficacy or safety data. Indeed, this was a CRL "light" so to speak. Mannkind met with the FDA June 2010 and submitted a class 2 resubmission which the FDA typically handles in about 6 months. Now the FDA in December stated that it would need about four more weeks in order to make a decision, but did not ask for more data. January 21, 2011 is about 6 months after the FDA originally accepted the resubmission. That is a good sign. It's not easy to predict FDA approvals, but it could be worth it here because many people are still skeptical, meaning that if Afrezza is approved the stock could increase in price substantially. Increasing that return could be a partnership which Al Mann (Mannkind's billionaire CEO, COB and 43% owner) has stated will probably happen after approval. This could be a very good time to own Mannkind shares. JR Themes: biotech, diabetes, insulin, inhaler, pharmaceutical, drug Stocks: MNKD |
|
| aus der Diskussion: | Mannkind, Game-Chancer in Sachen Diabetik? |
| Autor (Datum des Eintrages): | Magnetfeldfredy (11.01.11 13:02:26) |
| Beitrag: | 1 von 6,825 (ID:40838712) |
| Alle Angaben ohne Gewähr © wallstreetONLINE | |