One less Competition

[myocat]

AstraZeneca's Farxiga fails to get U.S. approval for Type-1 diabetes


(Reuters) - British drugmaker AstraZeneca Plc said on Monday the U.S. Food and Drug Administration declined to approve its diabetes treatment, Farxiga, for use as a supplement to insulin in adults with a rare-type of the condition.



The company said the regulator issued a complete response letter, declining its application for using the drug in patients with Type-1 diabetes where insulin alone has not been able to control blood sugar levels.



Farxiga is already approved in the United States for use in Type-2 diabetes, the more common form of the condition. AstraZeneca did not specify the concerns FDA had raised for not approving the drug for Type-1 diabetes.



The watchdog's decision is in contrast to that of its European counterpart, which earlier this year approved the treatment for use in Type-1 diabetes under the name Forxiga.



Type-1 diabetes is a condition in which the pancreas produces little or no insulin hormone and affects about 5% of patients with diabetes.



AstraZeneca said it would closely work with the FDA to chart out its next course of action.



Farxiga is one of the drugmaker's top 10 drugs by sales. It generated $1.39 billion in 2018, and is key to its future as it turns itself around.

[shawnonafrezza]

Farxiga wasn't competition. Afrezza is an insulin, Farxiga is a SGLT2 inhibitor. In the case of T1DM you'll always need the insulin so if anything this is just limiting patients who would benefit from a SGLT2 inhibitor and not going to really help Afrezza in any way.

Less competition would be Fiasp being pulled of URLi being denied.

[figglebird]

Well, technically, Shawn, it would be closer to competition from a real world standpoint than Fiasp imo - as I think Afrezza, or TS insulin, though catagorized as meal time(prandial) can be utilized in a broader manner due to its flexibility and so forth - wheras Farxiga as I understand it(though could be wrong) should not be taken with insulin due to potentially dangerous side effects etc.

Small point but one that I think underscores why many are so avid about the constraints that so fail to define what TS insulin really can/will be.

[sayhey24]

Jul 15, 2019 10:32:28 GMT -5 shawnonafrezza said:

Farxiga wasn't competition. Afrezza is an insulin, Farxiga is a SGLT2 inhibitor. In the case of T1DM you'll always need the insulin so if anything this is just limiting patients who would benefit from a SGLT2 inhibitor and not going to really help Afrezza in any way.

Less competition would be Fiasp being pulled of URLi being denied.

Just as GLP1s are being promoted with T1s to reduce excessive postprandial glucagon secretion, SGLT2s are being promoted to extracted excess sugar because the RAAs didn't do a good enough job at meal time.

Both are absolutely competition as they provide one more excuse for continuing to use the RAAs even though of their failure in controlling PPG and getting the PWD back to fasting  baseline.

Use the afrezza and there is no need for the RAAs, SGLT2s or GLP1s.  Use the afrezza with the T2 and there is little need for any other med.  As VDex would say, afrezza first, afrezza always.

[shawnonafrezza]

Sayhey24, you could (and I would) make the argument that Afrezza doesn't get around the benefit one could have with a SGLT2 med. There was just a video posted by sportsrancho on how some lady (Aferzza user) is waking up in the middle of the night to deal with hyperglycemia.

You all see competition where I see partnerships could be made. I've seen many sides of Afrezza since I first used it in 2014 (doctor side, rx side, patient side with pov and patient side as watching) and new things in the diabetes pipeline and if you think it's going to pick up with Afrezza first Afrezza always on it's own then we have very different opinions.

"Use the afrezza and there is no need for the RAAs, SGLT2s or GLP1s."

No, you replace one side of the coin for another, now you're monitoring your cgm and facing mental fatigue. Probably the biggest complain I had with Afrezza and many others. What could've helped that just got denied but as you all don't live with the disease you didn't see it. You see what you want because with the use of RAAs you don't need SLGT2s or GLP1s either but that is the tagline you'll try to sell yourself.