Talk:Insulin glargine/lixisenatide

sources

some sources here on the medical aspects.

On what is going on businesswise, this piece gives a sense of the current insulin pipeline. The development of this combination drug, started in 2003 per this Biospace piece. That article and this source describe why Sanofi is pushing this so hard (their patent on their insulin is expiring, and this is a typical line extension play) and how regulators have looked at this so far (not positively).

This hype-driven stub needs to be fixed or deleted.

I don't have time to fix this right now so I have tagged it and left some refs above. Jytdog (talk) 19:59, 20 September 2016 (UTC)

Could you identify specific lines in the article that you feel need verification and/or are written like an advertisement? NickCT (talk) 12:56, 21 September 2016 (UTC)

content about health needs to be sourced from MEDRS sources. The claim that there were "positive" results in a clinical trial are health claims, and the sources you brought are about as far from OK as one can get. Repeating Sanofi's claim it will get approval next year is WP:CRYSTALBALL - we don't do that here; we could fill pages with people's speculations about the regulatory and market opportunities/challenges for this drug. Wikipedia is not a stock price chat board. Please do read WP:NOT, WP:MEDRS, and WP:MEDMOS Jytdog (talk) 14:53, 21 September 2016 (UTC)

@Jytdog: - The wording wasn't suggesting the results were positive. It merely said that Sanofi claimed they were positive, which is both accurate and verifiable. We repeat claims from pharma companies in lots of different contexts on lots of different drug pages. The practice is not unusual.

Regardless, I like most of what you've done in the recent overhaul, though I find it slightly amusing that after citing WP:MEDRS so many times you've opted for some fairly obscure sources to support much of what you're putting in here.

Perhaps while we appear to be focused on this subject, we can turn our attention to Liraglutide/insulin degludec. That page looks like it could use some attention. NickCT (talk) 13:24, 26 September 2016 (UTC)

there is no biomedical information in the content I added. See above about "positive". You might repeat CRYSTALBALL claims from pharma companies in your editng; competent editors don't. Jytdog (talk) 20:29, 26 September 2016 (UTC)

@Jytdog: - re "competent editors don't." - Oh really? And where did you learn what competent editors do and don't do?

Anyways, excusing the childish behavior; looking at this edit; that first paragraph is essentially entirely about Lixisenatide. The article seems a little awkward as it's currently formatted, because half of it appears to be about a subject other than the actual combo. I take your point about the chronology, but I think it would still be a good idea to subsection these paragraphs for clarity. NickCT (talk) 13:34, 27 September 2016 (UTC)

The section is history. The single drug has its own story, the end of which overlaps the combination drug story - the FDA considered the first approval for the single agent in the same meeting as the combination drug.... something I have never heard of happening before. it is one story and breaking it into two sections makes no intrinsic sense. Jytdog (talk) 15:44, 27 September 2016 (UTC)

Hmmmmmm... It seems like you're trying to explain a lot of nuances behind the drug market and the race to develop insulin drugs. That's not necessarily a bad thing, but I feel like that story is a separate subject to the Insulin glargine/lixisenatide drug combo. Perhaps we can reword it a little to try to help the reader understand why there's a paragraph which seem to be talking exclusively about lixisenatide.

Also, can you point to the exact sourcing for the "concern in the committee". I'm having trouble seeing it. I'm also a little confused why this would cause concern. So what if the same people considering the single drug are considering the combo? If anything, that seems like it would be beneficial. NickCT (talk) 16:07, 27 September 2016 (UTC)

I thought you said you were from industry. The reason why the committee would be concerned is obvious. The Business Finance News source notes this : "According to the review, lixisenatide molecule has not established its efficacy alone, meaning that the investigational molecule will not provide any benefit to some group of patients if used as a single regimen...Furthermore, FDA has also raised a question on the benefits of lixisenatide to patients. The panel has scheduled a meeting on May 25, 2016, to make the final decision.." If you review the transcript of the meeting you will see that Sanofi noted this and people talked about it. Jytdog (talk) 16:16, 27 September 2016 (UTC)

Even folks in the industry struggle to make sense of nonsense.

Confusing. Your rationale seems disjointed. The sentence reads "same Endocrinologic and Metabolic Drugs Advisory FDA Committee that was considering lixisenatide as a single agent, which caused some concern in the committee". Can you point to exact source and sentence which says there was some concern in the committee about the fact that the same committee was considering lixisenatide?

It's possible there's some language issue here, but the rationale you provide above seems to be about why there might be concern over the efficacy of the drug. NickCT (talk) 17:05, 27 September 2016 (UTC)

I just did (and even provided a link to the transcript where even the sanofi rep says: "We're here today seeking the committee's endorsement for approval of lixisenatide and iGlarLixi for the treatment of adults with type 2 diabetes. Previously, we referred to iGlarLixi as LixiLan. Our presentations today will focus both on lixisenatide and iGlarLixi, as they're both under consideration for approval. We recognize that this is a unique situation and that our candidate iGlarLixi is the combination of two products, the first being FDA-approved Lantus, a well-established insulin glargine, and the second, lixisenatide, a GLP-1 receptor agonist, which is under review by FDA." Even the Sanofi rep acknowledged this. Jytdog (talk) 17:16, 27 September 2016 (UTC)

Looks to me like he recognized it was a "unique situation". I'm still looking for something that said it "caused some concern". NickCT (talk) 14:14, 28 September 2016 (UTC)

see above quotes. Jytdog (talk) 14:47, 28 September 2016 (UTC)

So I take it you're saying that the "concern" is explicit in that quote? Well...... I'm a little explicitly concerned that you might be reading in subtext which isn't there. Calling something a "unique" situation doesn't mean you're concerned about it. NickCT (talk) 14:53, 28 September 2016 (UTC)

I have no idea why you are making a big deal over this nor why you cannot see what is obvious in the RW and in the source provided; the content isn't that important so I'll remove it. Jytdog (talk) 15:03, 28 September 2016 (UTC)

Making a big deal? I'm just asking what exactly your reading that makes you think there was concern. And hey, maybe I'm wrong and misreading the quote you provided. Maybe "concern" is implicit in that statement. I'm just asking how you got to that interpretation. Seems like a reasonable question to me. It's not a big deal.... NickCT (talk) 15:26, 28 September 2016 (UTC)