Novo FIAsp approval coming?

[wsulylecoug]

Is this on deck and how might this affect Afrezza market? Is it a race for the first FDA labeled "ultra-rapid-acting" insulin?

[kbrion77]

Aug 7, 2017 12:42:54 GMT -5 wsulylecoug said:

Is this on deck and how might this affect Afrezza market? Is it a race for the first FDA labeled "ultra-rapid-acting" insulin?

For a board titled, "All About MNKD" this has hmmmmmmm absolutely nothing to do with MNKD.

[wsulylecoug]

Not meant to be anything more than a question about both shooting for the same first of it's kind label. I'm long MNKD. Don't take it any other way. This board has lots of knowledge I'm just trying to tap into. Nothing more. Feel free to lock or delete post, but I see it as something that could have a major impact on MNKD and Afrezza.

[dreamboatcruise]

Aug 7, 2017 12:42:54 GMT -5 wsulylecoug said:

Is this on deck and how might this affect Afrezza market? Is it a race for the first FDA labeled "ultra-rapid-acting" insulin?

An adjective on a label isn't a big deal in my opinion.

Novo getting the drug approved in US (with or without a different adjective) might even be good for Afrezza... having a company with much deeper marketing pockets making the case that current generation of RAA are too slow.  If doctors are made to questions speed of current RAA then they can look at pk/pd data for Afrezza and see that it beats Novo's new drug.

Though, and this will be a question that will play out in real world use, might Novo's new drug be deemed some sweet spot of faster than RAA but not requiring follow up doses as Afrezza might.  I still think overall it will be benefit at least getting doctors to think more about benefits of faster insulin.

[wsulylecoug]

Thanks DBC...Maybe I'm putting too much value on being the only "rapid" insulin, but with differentiating characteristics for both, it would be great if Afrezza has advantages beyond "rapid" as well. Haven't read the 9 studies from trials.gov to figure that out yet.

[dreamboatcruise]

Aug 7, 2017 13:01:34 GMT -5 wsulylecoug said:

Thanks DBC...Maybe I'm putting too much value on being the only "rapid" insulin, but with differentiating characteristics for both, it would be great if Afrezza has advantages beyond "rapid" as well. Haven't read the 9 studies from trials.gov to figure that out yet.

I don't think a word does anything to get better insurance/PBM coverage.  The pk/pd data is already available to doctors, so I don't think a word would make a difference for them.  I think for them it is having clinical results (A1c or time in range) tied to faster action and backed by professional marketing $$.  The one place I can see a word making a difference would be advertising to patients... where "the first approved ultra-rapid... " could get someone's attention.  But Mannkind doesn't have a budget to support national TV ads even if they had the word.  Novo will have the budget and Afrezza might just get some coattail action with patients going into their docs offices asking for the faster insulin and docs telling them that actually there is one even faster.

[mnholdem]

I disagree with your inferring that a new class of insulin would not matter to insurers. Any drug that achieves a First-In-Class status has huge advantages. This will be true with Afrezza if the treatment benefits of a faster insulin can be proven. This specific point is where I do agree with you to the extent that having deep-pocketed Novo-Nordisk provide empirical evidence of the benefits of an ultra-rapid acting insulin will benefit a company like MannKind, which as limited resources to prove Afrezza is a better treatment than slower RAAs.

[#NoMoreNeedles]

Their 10-Q calls out Fiasp and says that it is a potential threat to Afrezza's success.

[dreamboatcruise]

Aug 7, 2017 15:33:48 GMT -5 mnholdem said:

I disagree with your inferring that a new class of insulin would not matter to insurers. Any drug that achieves a First-In-Class status has huge advantages. This will be true with Afrezza if the treatment benefits of a faster insulin can be proven. This specific point is where I do agree with you to the extent that having deep-pocketed Novo-Nordisk provide empirical evidence of the benefits of an ultra-rapid acting insulin will benefit a company like MannKind, which as limited resources to prove Afrezza is a better treatment than slower RAAs.

So if Novo is First and Afrezza second shortly thereafter you feel insurers would favor Novo if/when they are convinced with clinical superiority (A1c, time in range) of faster at some point based on superiority trials?

I'd think at that point it would be more about Novo's marketing power with insurers and PBMs.

I'd sooner be second in class with Novo's marketing budget vs first with MNKD's.  And as you seem to agree, the clinical benefit proof is key to having the "class" be convertible to market share.  Nothing is great about having a large share of a tiny sub-market for a "class" of insulin not being used.

[peppy]

Aug 7, 2017 12:42:54 GMT -5 wsulylecoug said:

Is this on deck and how might this affect Afrezza market? Is it a race for the first FDA labeled "ultra-rapid-acting" insulin?

mnkd.proboards.com/thread/8105/faster-insulin-holy-grail-diabetes?page=1

Old news nothing to see here.

[dreamboatcruise]

Seems management is saying the class would make a difference. Reading between the lines it seems they've said PBMs have contracts with the likes of Novo that restrict what they can do with other competing RAAs and that these contractual problem would disappear if Afrezza goes into different class.

Everyone that dislikes me, you can note here where I've admitted to having been too skeptical... put it to good use

[wsulylecoug]

Based on CC, if all goes well with FDA in September, Afrezza will be the first ultra?

[lennymnkd]

Practically... real time 5 MINUTES ... 😀👍

[wsulylecoug]

Being in their own "bucket" sounds like a good place to be.

[letitride]

Afrezza should be labeled fast acting and the rest should have to remove that designation!