Category Archives: DPP-IVi

CARMELINA CVOT Neutral; No Mention of Superiority

Boehringer Ingelheim and Lilly have announced topline results from CARMELINA, the Tradjenta CVOT, which demonstrated no increased CV risk. BI/Lilly did not discuss whether or not CARMELINA met superiority, but it is assumed the trial was neutral given results from the other DPP-IVi CVOTs. Below, FENIX provides insight into the results including implications from the pre-specified superiority testing plan.

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Oral Semaglutide Superior to Januvia at 78 Weeks (PIONEER 3)

Novo Nordisk has announced topline results from the PIONEER 3 study demonstrating superiority in A1C and weight loss at 26 and 78 weeks for 7 and 14 mg oral semaglutide vs. 100 mg Januvia. 3 mg oral semaglutide was statistically significantly inferior to Januvia in A1C. Below, FENIX provides additional insight into oral semaglutide development based on the results from PIONEER 3.

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Drug ADA ‘18 Key Data Press Releases (June 23)

21 major press releases featuring new data presented at ADA ’18 were observed across diabetes drugs, devices, and apps, a major increase from 9 on the first day of ADA ‘17. Below, FENIX has provided context and analysis for 14 drug-related announcements, with analysis of device and app-related announcements to follow in a separate alert.

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AZ Q1 ‘18 Earnings Updates

AZ hosted their Q1 ’18 earnings call and briefly discussed their diabetes portfolio, with a particular focus on Farxiga, including H2 ‘18 readout of the DECLARE CVOT and planned H2 ’18 US filing in T1DM.

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Lilly Q1 ’18 Earnings Update

Lilly hosted its Q1 ’18 earnings call (press release) and provided updates on its diabetes business unit. Of note, Lilly affirmed REWIND (Trulicity CVOT) topline readout is anticipated in early Q4 ’18 with full results at ADA 2019. Below are highlights from the call.

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AZ Q4 ’17 Earnings Update

AZ hosted their Q4 ’17 earnings call (press release) and briefly discussed their diabetes portfolio, with a particular focus on Farxiga and Bydureon.

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Merck Q4 ’17 Earnings Update

Merck hosted their Q4 ’17 earnings call and briefly discussed Januvia and the newly-approved Stegaltro franchise.

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FENIX SGLT2i pricing analysis

FENIX has conducted a pricing analysis of the SGLT2i and SGLT2i+DPP-IVi FDC classes.

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Lilly Q1 ’17 Earnings Update

Lilly hosted its Q1 ’17 earnings call and provided an update to its diabetes portfolio including pipeline and LCM activities.

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Lilly Initiates Ph1 for New OAD

A Lilly sponsored Ph1 ClinicaTrials.gov record has been observed for LY3325656. According to the record, the compound is dosed orally and is being compared to liraglutide and in combination with sitagliptin. MOA for LY3325656 remains to be determined.

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