Diabetes Analyst Webchat: Q/A Transcript.
View the full list of questions and answers below
Following our live Analyst webchat on LinkedIn last week focused on key developments across key pipeline and marketed diabetes treatments, we are happy to share the session highlights with you below with a transcript of the Q&A. Thank you to those who took part – we hope you found the insights valuable and look forward to further Q&A’s in the future.
For those that missed out, don’t forget to join Datamonitor Healthcare on LinkedIn to stay updated to future events and analyst insight.
Analyst Webchat Transcript: Diabetes
(All answers were provided by our Sebastian Heinzmann, one of our Cardiovascular and Metabolic Diseases Analysts.)
- Q. How did Lilly’s data at ADA effect your opinion and outlook for dulaglutide? What’s the potential for this drug?
A. The data presented looks quite promising. Efficacy results are excellent and it looks like dulaglutide compares to Victoza in terms of HbA1c reduction… the side effect profile also looked good – so we believe the potential is quite high. There’s reduced, once-weekly dosing, which is an advantage over Victoza
- Q. What are your thoughts on market access for DPP-IV inhibitors and GLP-1 agonists in emerging markets?
A. I think running trials globally is a benefit. Dapagliflozin, for example, was investigated in several emerging markets, which allows for quicker approval in those countries.
- Q. What would you say the potential for BI/Lilly’s new SGLT2 inhibitor, empagliflozin?
A. The trial data looks quite good in terms of efficacy and side effect profile, but it doesn’t quite reach the efficacy of J&J’s canagliflozin. Additonally, canagliflozin has got the ‘first to market’ advantage in the US, while in the EU, Forxiga (dapagliflozin) has that advantage. That’s going to be difficult to beat, but there are opportunities in the fixed-dose combination market.
- Q. Do you think the DPP-IV market is saturated or is there any room for new entrants? Will market growth stop due to GLP-1 agonists and SGLT2 inhibitors?
A. The market is getting saturated, yes. In the US, there’s Januvia, Tradjenta, Onglyza, and Nesina… there’s barely any difference in terms of efficacy and side-effect profile, so the drugs are interchangable. SGLT-2 inhibitor Invokana already seems to be taking some share from Januvia. Considering obesity incidence is on the rise, weight-reducing therapies will capture more market share in the future.
- Q. Lilly said dulaglutide underwent rigorous safety testing. There are still lingering questions about the GLP-1 drug class. Can you give your thoughts on the safety question?
Rigorous safety testing usually relates to CV safety and more acute adverse events. The question of whether incretin mimetics cause pancreatic tissue changes/neoplasia is more of a long-term question. Novo Nordisk recently said they have long-term data on Victoza, but personally I think you would need longer-term studies, not just 2-4 years. Also, it is not necessarily the amount of patient years that is relevant, but also how long each individual patient was followed up for.
- Q. Were you surprised by dulalgutide’s poor GI tolerance profile relative to Bydureon or albiglutide?
A. We noted dulaglutide’s slightly poorer GI tolerance, but at the same time it showed better efficacy than Bydureon and albiglutide. It’s a trade-off. Albiglutide’s efficacy disappointed somewhat and we don’t see that much potential for this drug if the price is going to be similar to that of dulaglutide. Albiglutide showed lower efficacy and failed to demonstrate non-inferiority to Victoza, so I think doctors may prefer dulaglutide. The HbA1c lowering efficacy and weight loss we saw with albiglutide can also be achieved with SGLT-2 inhibitors, so doctors may prefer to prescribe them for cost and convenience reasons.
- Q. Some of the data presented at ADA 2013 showed a GLP-1 with 2 years primary end-point efficacy vs DPP-4 and SU? Is this a new approach to demonstrating long-term efficacy?
A. I don’t think it’s an entirely new way… it’s more of an approach to differentiate a compound from its competitors to demonstrate 2-year rather than 26 or 52-week efficacy vs. DPP-IVs and Sus.
- Q. You mentioned the potential for novel fixed-dose combinations – any thoughts on dapagliflozin/saxagliptin or other DPP4/SGLT2 FDCs?
A. We think that currently Invokana is being added on to Januvia/metformin or just to metformin, rather than many patients switching. So giving patients the option to have a DPP-IV inhibitor and SGLT-2 combined will ease the pill burden, while you can still have an easily adaptable metformin regimen. SGLT-2 inhibitors are also a good way to counteract the effects of pioglitazone in terms fluid retention and weight gain, so FDCs of SGLT-2 and metformin added on to pioglitazone could prevent weight gain in a number of patients that need treatment intensification.