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Post by goyocafe on Apr 25, 2018 19:47:33 GMT -5
Just because the REMS communication plan is complete does not mean the black box warning for bronchial spasms (which is what the REMS plan was for) goes away. Competitors can still use it against Afrezza as long as it is on the label. Its not the communication plan which is complete, it is the REMS. The communication plan was the vehicle for communicating the risks of afrezza and has met its goals. The FDA has decided that a REMS is no longer required for Afrezza, i.e. "complete". From the press release - "The Food and Drug Administration (FDA) has completed its review of a supplemental New Drug Application (sNDA) for Afrezza (insulin human) inhalation powder and has determined that the Risk Evaluation and Mitigation Strategy (REMS) communication plan regarding the risks of Afrezza has been completed and has met its goals. As a result, the FDA has decided that a REMS is no longer required for Afrezza." How did this happen? MNKD submitted an sNDA and the sNDA was approved. I suspect the next step is the negotiation of the new label now that the sNDA is approved. Two key points of the REMS was the spirometry testing and notification of bronchial spasms. While I expect the spirometry will be suggested in the future it will no longer be required. I also expect the bronchial spasms warning to stay on the label just not in the black box. Who knows, maybe we will hear what the new label is by ADA2018. As far as competitors using bronchial spasms against afrezza, how many people is this really effecting? I would guess not many. If thats the best the competitors have to compete on, that IMO sounds like great news for afrezza. I read on Afrezza Facebook yesterday a story about a woman experiencing throat constrictions and breathing problems. She thought it was Afrezza. Turned out she was allergic to Tresiba. Now there’s a curve ball for all the injected RAAs. Facebook Tresiba Allergy |
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Post by dreamboatcruise on Apr 25, 2018 20:03:11 GMT -5
My question for Dr. Kendall would be what data was submitted with the sNDA that allowed the FDA to make the decision a REMS is no longer required? Was it from the 60+ lost studies or clinical results over the last 3 years or both? The wording from MNKD makes it sound like it wasn't new (or old) clinical data, but rather a determination that what needed to be communicated has been. Seems a bit strange that would be the case, but that's what it appears to say. |
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Post by sayhey24 on Apr 25, 2018 20:42:23 GMT -5
My question for Dr. Kendall would be what data was submitted with the sNDA that allowed the FDA to make the decision a REMS is no longer required? Was it from the 60+ lost studies or clinical results over the last 3 years or both? The wording from MNKD makes it sound like it wasn't new (or old) clinical data, but rather a determination that what needed to be communicated has been. Seems a bit strange that would be the case, but that's what it appears to say. What the release says is they submitted an sNDA. What was submitted in the sNDA to justify the REMS no longer being needed? I would think you need study data. Mike's good looks are probably not good enough with out solid data. Al had all kinds of lung safety data. They use to xray the study candidates before and after plus the mouse studies. I suspect MNKD was not yet ready to announce the sNDA but the info about the REMS was found on the FDA website and it was signed yesterday so it was hot off the press. With social media blowing up over the REMS they were forced into this evening's PR. |
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Post by agedhippie on Apr 25, 2018 21:36:18 GMT -5
The wording from MNKD makes it sound like it wasn't new (or old) clinical data, but rather a determination that what needed to be communicated has been. Seems a bit strange that would be the case, but that's what it appears to say. What the release says is they submitted an sNDA. What was submitted in the sNDA to justify the REMS no longer being needed? I would think you need study data. Mike's good looks are probably not good enough with out solid data. Al had all kinds of lung safety data. They use to xray the study candidates before and after plus the mouse studies. I suspect MNKD was not yet ready to announce the sNDA but the info about the REMS was found on the FDA website and it was signed yesterday so it was hot off the press. With social media blowing up over the REMS they were forced into this evening's PR. Read the documents, that is simply wrong. The REMS is no longer needed because the communications have been done. It's in black and white in the FDA letter. |
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Post by agedhippie on Apr 25, 2018 21:47:56 GMT -5
My question for Dr. Kendall would be what data was submitted with the sNDA that allowed the FDA to make the decision a REMS is no longer required? Was it from the 60+ lost studies or clinical results over the last 3 years or both? The wording from MNKD makes it sound like it wasn't new (or old) clinical data, but rather a determination that what needed to be communicated has been. Seems a bit strange that would be the case, but that's what it appears to say. The REMS required communication of the bronchial spasm risk, what had to be sent, and who it had to be sent to are in this letter - REMS - FullFrom the FDA letter: We have determined that the communication plan is no longer necessary as an element of the REMS to ensure the benefits of Afrezza (insulin human) inhalation powder outweigh its risks because the communication plan has been completed and the most recent assessment demonstrated that the communication plan has met its goals.The communication is complete therefore the plan is no longer needed, therefore the REMS (which was that " MannKind Corporation will implement the following communication plan to healthcare providers likely to prescribe AFREZZA") is also complete, and rather obviously no longer required. Perfectly straight forward, and does not require any fantasies about nebulous clinical data  |
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Post by digger on Apr 25, 2018 23:47:05 GMT -5
No, plenty of drugs have cleared REMS and they all still have the same long warnings at the end of TV and magazine ads. If that's the case, can you name any drugs that are inhaled that have cleared REMS and still have the same long warnings....... Well, bydureon for one -- www.bydureon.com/ You can get the entire list of past REMS drugs that have been cleared here -- www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsData.pageThey're excel files, but if you don't have that, you still read them online here -- sheet.zoho.com/sheet/excelviewerI doubt you'll find any that don't still have the same old warnings. |
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Post by dreamboatcruise on Apr 26, 2018 0:33:55 GMT -5
The wording from MNKD makes it sound like it wasn't new (or old) clinical data, but rather a determination that what needed to be communicated has been. Seems a bit strange that would be the case, but that's what it appears to say. The REMS required communication of the bronchial spasm risk, what had to be sent, and who it had to be sent to are in this letter - REMS - FullFrom the FDA letter: We have determined that the communication plan is no longer necessary as an element of the REMS to ensure the benefits of Afrezza (insulin human) inhalation powder outweigh its risks because the communication plan has been completed and the most recent assessment demonstrated that the communication plan has met its goals.The communication is complete therefore the plan is no longer needed, therefore the REMS (which was that " MannKind Corporation will implement the following communication plan to healthcare providers likely to prescribe AFREZZA") is also complete, and rather obviously no longer required. Perfectly straight forward, and does not require any fantasies about nebulous clinical data Darn... I like fantasies... dreaming about kissing a prince and having him turn into a lizard.  |
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