As a follow-up to our drug analysis of 14 press releases, FENIX has provided context and analysis for 7 device and app-related announcements.
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.
Senseonics has announced approval of Eversense, their implantable CGM, in the US and held an investor call. Of note, Senseonics did not mention anything regarding the updated components discussed during the adcom (sensor end cap and insertion tool); however, it was approved with the smaller gen 2 transmitter. Below, FENIX has conducted an analysis of the approval, safety labeling, and market implications.
Tandem announced FDA approval of its t:slim X2 insulin pump with Basal-IQ technology which utilizes a predictive low-glucose suspend (PLGS) feature, curiously with Dexcom G6 rather than G5 as previously communicated. Additionally, FDA has expanded the approval of the Medtronic MiniMed 670G to include children aged 7 to 13 with T1DM.
Voluntis and Monarch Medical Technologies have announced a strategic collaborationto integrate Voluntis’s personal T2DM diabetes platform (Insulia) with Monarch’s in-patient insulin titration tools (EndoTool IV and EndoTool SubQ). Below, FENIX provides insight into the collaboration including perspective on competition to Glytec who provides a similar product.
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.
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.
Novo Nordisk has announced a partnership with Kallyope for the discovery of peptides to treat diabetes and obesity. Below, FENIX provides thoughts on the Novo/Kallyope collaboration and apparent change in R&D strategy.
The DreaMed FDA approval for its Advisor Pro algorithm now empowers Glooko to compete with Medtronic’s CareLink across the patient and provider customer segments. Below, FENIX provides insight into Glooko’s enhanced position to compete with Medtronic’s CareLink in diabetes decision support services.
Medtronic announced it has expanded its partnership with Nutrino to integrate an updated FoodPrint App with the iPro2 professional CGM. Below, FENIX provides insight into the potential impact of the new feature and future application.