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Post by Earl Grey on Sept 19, 2014 14:09:25 GMT -5
FDA Approves Eli Lilly's Injectable Diabetes Drug Thu, 09/18/2014 - 4:41pm The Food and Drug Administration has approved a new injectable diabetes drug from Eli Lilly and Co. for adults with the most common form of the disease. The agency on Thursday cleared the drug, Trulicity, as a weekly injection to improve blood sugar control in patients with type 2 diabetes, which affects more than 26 million Americans. The drug is part of a new class of medicines called GLP-1 agonists, which spur the pancreas to create extra insulin after meals. Type 2 diabetes accounts for 90 percent of U.S. cases of the disease and occurs when the body doesn't properly produce or use the hormone insulin. Drugs to treat the disease represent a large slice of Lilly's product portfolio, which includes the insulins Humalog and Humulin. Indianapolis-based Lilly is counting on new drugs like Trulicity to replace falling revenue from blockbusters like the antidepressant Cymbalta, which is facing cheaper generic competition after the expiration of its patent. The FDA approved Trulicity based on six studies in 3,342 patients that showed improvements in blood sugar control. The drug was studied as a stand-alone therapy and in combination with other commonly used diabetes drugs, such as metformin. The drug will bear a boxed warning— the most serious type— highlighting that rats tested with Trulicity had cases of thyroid cancer, though it's unclear whether they were caused by the drug. Lilly will be required to conduct follow-up studies on cases of thyroid cancer, heart problems and other potential safety issues with the drug. The FDA is also requiring Lilly to educate doctors about the drug's various risks. www.dddmag.com/news/2014/09/fda-approves-eli-lillys-injectable-diabetes-drug?et_cid=4162635&et_rid=210377746&location=topGet a weekly shot, or inhale per meal ?? Guess it depends on how much you feel like a rat !!
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Post by mannmade on Sept 19, 2014 15:48:05 GMT -5
Have a couple questions/thoughts for the board on the above... 1.) Still a GLP-1 and as I understand it they have recently been linked to Alzheimer's, 2.) Even though once a week, GLP's do not stop the slide into insulin dependency, so wonder if same here? If so then seems Afrezza would be better choice if goal is ultimately to prevent further deterioration in patient health from progress of diabetes over time... My current understanding of Al's position on this is that Afrezza will eventually replace GLP's as first line of treatment in T2's. Not sure if any of this changes with this new drug... So in my mind with what I currently know about Afrezza (and may not know about Trulicity,) seems based on the science behind each, the choice is still clear to me... And that's Afrezza... (Weekly Injection vs Inhalation is just another "cosmetic benefit" as I like to call it..) Remember the Science! GLTA!
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Post by mannup on Sept 19, 2014 17:07:04 GMT -5
The most common side effects found in people taking Trulicity were nausea, diarrhea, vomiting, abdominal pain, and decreased appetite.
The FDA said that it would require Lilly to perform a number of post-marketing studies, including a cardiovascular outcomes trial, a trial in pediatric patients, and a long term (15 year) registry to identify any increase in the rate of MTC.
Lilly will also be required to implement a Risk Evaluation and Mitigation Strategy (REMS), in which the company will inform physicians and other healthcare professionals about the serious risks linked to the drug.
Trulicity will compete against several other GLP-1 receptor agonists, including exenatide (marketed as Byetta and Bydureon by AstraZeneca), liraglutide (marketed as Victoza by Novo Nordisk), and albiglutide, marketed as Tanzeum by GSK.
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Post by mnholdem on Sept 20, 2014 7:42:14 GMT -5
A reminder: Afrezza will also work great with long-actings that compete against Sanofi's arsenal. Short-term, Sanofi will be pushing it's own combination of Lantus-Afrezza, then Toujeo-Afrezza. But long-term, is there any doubt Afrezza will become Sanofi's new #1?
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Post by jpg on Sept 20, 2014 16:42:47 GMT -5
A reminder: Afrezza will also work great with long-actings that compete against Sanofi's arsenal. Short-term, Sanofi will be pushing it's own combination of Lantus-Afrezza, then Toujeo-Afrezza. But long-term, is there any doubt Afrezza will become Sanofi's new #1? Looking at the MNKD market cap the market certainly seems to be pricing future sales of Afrezza very differently then most of us. That is the beauty of markets. We shall son see who is right. With a few painful detours (and extraordinary buying opportunities) we have been right so far. JPG
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