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Post by suebeeee1 on Nov 16, 2015 11:46:55 GMT -5
So this is a different entity from the last "insulin human" applications we've seen pop up on EMA reviews? How can you tell its an "initial application"? If this is Afrezza, whether its the first step in the process or the last, it would be a very encouraging sign that SNY would seek to enter another market with MNKD. Since I am not adept at doing "screen shots" you'll have to open the link given by Harry. It is listed in the index and then in the body of the document. |
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Post by jeremg on Nov 16, 2015 11:58:44 GMT -5
suebeeee1, I have reviewed the EMA documentation: 3.1.11. - insulin human - EMEA/H/C/003858 treatment of diabetes Scope: Opinion Action: For adoption Oral explanation was held on 20 October 2015. List of Outstanding Issues adopted on 25.06.2015. List of Questions adopted on 23.10.2014. Unless I'm missing something, I don't see how this isn't the same "insulin human" that has popped up many times before, and most have concluded it is likely NOT Afrezza.
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Post by cathode on Nov 16, 2015 12:05:20 GMT -5
suebeeee1, I have reviewed the EMA documentation: 3.1.11. - insulin human - EMEA/H/C/003858 treatment of diabetes Scope: Opinion Action: For adoption Oral explanation was held on 20 October 2015. List of Outstanding Issues adopted on 25.06.2015. List of Questions adopted on 23.10.2014. Unless I'm missing something, I don't see how this isn't the same "insulin human" that has popped up many times before, and most have concluded it is likely NOT Afrezza. From October: 2.1.1. - insulin human - EMEA/H/C/ 003858treatment of diabetes Scope: Oral explanation Action: Oral explanation to be held on Tuesday 20 October 2015 at 9.00. List of Outstanding Issues adopted on 25.06.2015. List of Questions adopted on 23.10.2014. From November: 3.1.11. - insulin human - EMEA/H/C/ 003858treatment of diabetes Scope: Opinion Action: For adoption Oral explanation was held on 20 October 2015. List of Outstanding Issues adopted on 25.06.2015. List of Questions adopted on 23.10.2014. |
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Post by kc on Nov 16, 2015 14:52:24 GMT -5
Not sure how we track back to this filing. I think its strange it does not list who the sponsor was.
3.1.11. - insulin human - EMEA/H/C/003858
treatment of diabetes
Committee for medicinal products for human use (CHMP)
EMA/CHMP/754777/2015 Page 11/31
Scope: Opinion
Action: For adoption
Oral explanation was held on 20 October 2015. List of Outstanding Issues adopted on 25.06.2015. List of Questions adopted on 23.10.2014.
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Post by charlespk on Nov 16, 2015 15:52:52 GMT -5
Hope ,it is Afrezza , but most of " human insulin " now a days is recombinant human insulin as i have said before , as opposed to the old days whne it was derived form pork etc .
So " Human Insulin " could be a biosimilar like so many of you have stated .
Would assume that SNY application for EMA approval is a significant event that they would have to disclose.
will see
As always , long MNKD
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Post by liane on Nov 16, 2015 15:58:16 GMT -5
Human insulin is identical to that made by the human pancreas - even though it is made through a recombinant DNA process. In the old days - "pork insulin", or porcine insulin was just that - it was derived from pigs. It is not identical to human insulin. The RAA's today - such as insulin glargine etc are unlike any insulin found in nature. Usually there is a single amino acid substitution to give it different properties than natural human insulin.
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Post by suebeeee1 on Nov 16, 2015 16:03:43 GMT -5
suebeeee1, I have reviewed the EMA documentation: 3.1.11. - insulin human - EMEA/H/C/003858 treatment of diabetes Scope: Opinion Action: For adoption Oral explanation was held on 20 October 2015. List of Outstanding Issues adopted on 25.06.2015. List of Questions adopted on 23.10.2014. Unless I'm missing something, I don't see how this isn't the same "insulin human" that has popped up many times before, and most have concluded it is likely NOT Afrezza. In the past, the insulin was listed as "bio-similar". This is not listed that way. Of course, it would seem to me that it is the technosphere process that must be approved. |
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Post by kc on Nov 16, 2015 16:32:08 GMT -5
Can Afrezza be considered a Bio-Simular? being simular to injection insulin?
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