F.D.A. Panel Splits on Whether to Approve New Diabetes Drug


#1

The advisory committee voted 8-8 on approving the drug, to be called Zynquista, which would be the first oral medication for people with Type 1 diabetes.

An advisory panel for the Food and Drug Administration split evenly on Thursday over whether the agency should approve the first oral medication to treat Type 1 diabetes.

The committee voted 8-8, leaving it up to the agency to decide by the end of March whether the drug, sotagliflozin, should reach the market.

The drug, which is used along with insulin, is being developed by the drug makers Sanofi and Lexicon Pharmaceuticals, who plan to sell it under the brand name Zynquista. It carries a higher risk for developing diabetic ketoacidosis, a life-threatening complication that happens when the body doesn’t get enough insulin, which led some of the reviewers to vote against it.

The companies said they would continue work with the F.D.A. throughout the review process.

The drug is a once-daily pill designed to help people manage their blood sugar levels. In Type 1 diabetes — also known as juvenile diabetes because it is often diagnosed in childhood — the body does not produce insulin, so people with the disease must monitor their blood sugar and take insulin. But relying on external insulin can lead the body’s blood sugar levels to rise and fall, which is uncomfortable and can lead to health problems.

Read more HERE: https://www.nytimes.com/2019/01/17/health/fda-diabetes-drug-sanofi.html


#2

After reading the article, I’d say I’d vote against it if it were up to me.


#3

As I suspected…

“Like some other recently approved drugs for people with Type 2 diabetes — including Invokana and Jardiance — this one causes the body to excrete more blood sugar into the urine.”

I think some T1Ds use the existing T2 drugs. Not clear why a new one is needed.


#4

Pharm company would want a new one for two reasons—first, it can be prescribed without being off-label, so more people will use it (probably lots of docs hesitant to prescribe the T2 meds to T1s), and two, if it’s actually a new formulation (as opposed to a rebranding) it prolongs the time before a generic can be used for those individuals taking the new one. Lots of drugs get renamed/branded for new applications though, like Wellbutrin (anti-depressant) is also Zyban (smoking cessation aid)—both are the drug bupropion.


#5

Money. Newer drugs usually cost more than previous ones.


#6

I recall reading something that said some Doctors are dinged for doing too many off label RX. Unfortunate when best interest of patient is not the primary goal.


#7

A ratio of a bit over 1:10 for DKA in users versus placebo seems high to me. I realize it was a small percentage of the overall, but like the article says, “in the real world”, those numbers are going to translate higher…and that’s a lot of DKA.


#8

I started on Jardiance a couple of months ago. Definitely helps flatten things out and lowers my TDD. This article doesn’t say much about the particulars of the new drug–if it works analogously to the T2 ones or what. It would be useful to know what makes it T1D-specific.

But relying on external insulin can lead the body’s blood sugar levels to rise and fall, which is uncomfortable and can lead to health problems.

Pretty mild way of putting it…


#9

"

Sotagliflozin is an orally-delivered small molecule compound that we and Sanofi are developing for the treatment of type 1 and type 2 diabetes mellitus. Sotagliflozin was internally generated by our scientists and inhibits both sodium-glucose cotransporter 2, or SGLT2, a transporter responsible for most of the glucose reabsorption performed by the kidney, and sodium-glucose cotransporter 1, or SGLT1, a transporter responsible for glucose and galactose absorption in the gastrointestinal tract. Our scientists identified mice lacking SGLT1, SGLT2 or both as having potent anti-diabetic phenotypes across multiple measures of glucose control and metabolism, and found that compounds inhibiting both targets had a favorable preclinical profile relative to compounds selective for SGLT2."


#10

So basically the same thing Jardiance does, sounds like (I am not a biochemist).


#11

What is “TDD”?

Thanks.
M.


#12

Total Daily Dose of insulin which includes both basal and bolus dosages.