Drug proved as effective as long-acting insulin
* Drug also showed benefits when used with other treatments
(Reuters) - Eli Lilly & Co's experimental once-weekly diabetes drug dulaglutide proved as good as insulin in controlling blood sugar in type 2 diabetics in two late-stage studies, the company said on Tuesday.
Afrezza is a bolus insulin this is a basal insulin. Really Oddo? For someone as active as you are on this MB you should know better. What is your game here? Shorty? I believe we will have superiority in efficacy. Non-inferiority is even okay because when you drop hypo's significantly you really have a winner. Cut out many acute deaths.
Sentiment: Strong Buy
No. This is not a threat. In fact., Lily is a prime candidate to partner with or buy out Mannkind.
Once-a-week dulaglutide, if approved, would be complementary to -- not competitive with -- Afrezza, if approved. In trials that compared dulaglutide to insulin, it was a basal insulin that was being compared, not a prandial insulin like Afrezza. In fact, in one of the trials (AWARD-4) dulaglutide was used with lispro, a fast-acting prandial insulin.
Quote: "For the study, Holman's team compared different forms of insulin therapy for patients with type 2 diabetes. Insulin treatment can start with a "basal" dose that is long-acting, a "prandial" or mealtime dose of insulin that is short-acting or a so-called biphasic dose, a mixture of both short and long-acting insulin.
However, which of these regimens works best was not clear, Holman said. To find out, the researchers randomly assigned 708 patients to biphasic insulin injections twice a day (NovoMix30), mealtime insulin injections three times a day (NovoRapid) or basal insulin injected once a day (Levemir). All of the formulations are made by Novo Nordisk.
These patients had poor blood sugar control even though they were taking two common oral diabetes medications, metformin and sulfonylurea, the researchers noted.
Three years into the trial, the researchers found that slightly more than 43 percent of the patients taking basal insulin and about 45 percent of the patients taking insulin at mealtime achieved good blood sugar control, compared with about 32 percent of those taking biphasic insulin."
You will notice that mealtime insulin provided superior results over basal insulin, however, the basal insulin was originally recommended first because it resulted in less weight gain. Since in prior T2 trials Afrezza has already proven superior to other RAA and in addition, there is minimal if any weight gain it would be the recommended treatment for T2 diabetics that need to start using insulin. Since Lilly will be submitting dulaglutide for initial approval with the FDA (which they have not done yet) and that will mean a 12 month approval period, then that also means that Afrezza would be approved prior to dulaglutide receiving approval. The FDA will then have to decide whether they should approve dulaglutide, or require Lilly to do another P3 trial comparing dulaglutide to Afrezza which I could easily see the FDA doing.
One additional thing to add to my first reply. Quote: "The dulaglutide 1.5 mg dose in combination with insulin lispro demonstrated statistically superior reduction in HbA1c from baseline compared to insulin glargine in combination with insulin lispro at 26 weeks (AWARD-4)." You will note that the superior performance that dulaglutide showed was when used in combination with insulin lispro (a mealtime insulin). In you look at my first post above, the combo approach resulted in the least improvement. So I do not see where dulaglutide is any threat to Afrezza at all. However, Afrezza could significantly reduce the market potential of dulaglutide.
Right on the money about that info. No way the FDA can pass that.
Unless they have a disclaimer: MAY CAUSE ALZHEIMERS
If Dulaglutide passes and AFREZZA is rejected there is no hope. The system is flawed and hopeless.
On a separate note I will be shorting LLY, i just need to call that crapstein character to write an article to post on seekingalpo, then watch the money start coming in!!!
Sentiment: Strong Buy