Tag Archives: NVO

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.

This content is for Read Less members only.
Register
Already a member? Log in here

ADA ’18 Key Data Press Releases (June 24)

4 major press releases featuring new data presented at ADA ’18 were observed across diabetes drugs and devices. Below, FENIX has provided context and analysis of these announcements.

This content is for Read Less members only.
Register
Already a member? Log in here

New Novo CVOT strategy; ADA ’18 Analyst Briefing

Novo hosted its annual ADA analyst briefing (presentation slides), predominantly discussing oral semaglutide. Of note, Novo disclosed they are no longer conducting a large-scale CVOT for Ozempic (formerly SOUL), instead leveraging the results of both SUSTAIN 6 and PIONEER 6 between injectable and oral semaglutide. Novo senior management said they believe it will be difficult for PIONEER 6 to demonstrate CV benefit at p < 0.05 given the low number of pre-specified events will require a large reduction in the hazard ratio. Additionally, Novo stated they plan to file oral semaglutide in mid-2019. Below are highlights from the ADA analyst event including three potential scenarios for injectable and oral semaglutide CV indications.

This content is for Read Less members only.
Register
Already a member? Log in here

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.

This content is for Read Less members only.
Register
Already a member? Log in here

More Thoughts on PIONEER-4 and Potential Novo Regulatory Strategy for Oral Semaglutide

For the four Ph3a oral semaglutide trial data disclosures thus far, Novo has consistently discussed two statistical analyses performed: on-treatment and intention-to-treat. FENIX believes this directly plays into Novo’s oral semaglutide regulatory strategy including preparing for an FDA adcom, the submission dossier, and proposed product label. Below, FENIX discusses more thoughts in the context of the PIONEER-1 study and potential label implications from Novo’s statistical representations that could allow for PIONEER-4 superiority vs. Victoza in the label.

This content is for Read Less members only.
Register
Already a member? Log in here

Novo Suspends Ph1 Stable Glucagon Analog Study

The CT.gov record for Novo’s Ph1 stable glucagon analog study (NN9030) has been updated, and the trial is now listed as “Suspended (Evaluation of data).” Below, FENIX provides potential scenarios for the recruitment suspension.

This content is for Read Less members only.
Register
Already a member? Log in here

Novo’s Oral Semaglutide Beats Victoza and Januvia

Novo Nordisk has announced topline results from the Ph3 PIONEER 4 (vs. 1.8mg Victoza) and PIONEER 7 (3, 7, and 14 mg oral sema dose escalation vs. Januvia) studies. Both trials met their primary outcomes (non-inferiority to Victoza and superiority to Januvia), and oral semaglutide also demonstrated statistically significant A1C and weight reduction vs. Victoza. Additionally, FENIX provides insight into a potential relationship between PIONEER 7 dose escalation and discontinuation rates observed in the reported PIONEER studies.

This content is for Read Less members only.
Register
Already a member? Log in here

New Fiasp/Medtronic 670G Study on CT.gov

A CT.gov record for a study evaluating Novo’s Fiasp (faster-acting insulin aspart) in a Medtronic 670G pump has been observed. This Ph4 study is sponsored by Bruce Buckingham’s lab at Stanford, and Medtronic is listed as a collaborator (Novo is not believed to be part of the study). Recall, the Fiasp label does not include designation for use in insulin pumps. Below, FENIX provides insight into the use of ultra-rapid-acting insulin in pumps as well as why a future commercial partnership between Novo and Medtronic could make sense.

This content is for Read Less members only.
Register
Already a member? Log in here

Victoza T2DM Pediatric Study Completed

The CT.gov record for Novo’s pediatric Victoza study (ELLIPSE) has recently been updated to “completed.” Assuming Novo files ELLIPSE by the end of Q2 ’18, approval is projected in H1 ’19 with an 8 to 10-month review. Below, FENIX provides implications and market context for the Victoza pediatric label update.

This content is for Read Less members only.
Register
Already a member? Log in here