Category Archives: Topics

Thoughts on New ACC T2DM ASCVD Recommendations

The ACC published their 2018 ACC Expert Consensus Decision Pathway on Novel Therapies for CV Risk Reduction in Patients with T2DM and ASCVD in JACC. Notably, the ACC recommends SGLT2i use for potential CV benefits and GLP-1RA use for those patients who may have an unsuitable risk profile for SGLT2i use. Below, FENIX provides a winners-and-losers analysis based on the recent ACC recommendations compared to the updated ADA/EASD guidelines from October 2018.

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

Invokana CANVAS promotion observed on patient and HCP websites

J&J recently updated the Invokana patient and HCP websites to reflect the recent approval of the Invokana CV indication, i.e., reduction of 3P-MACE from CANVAS/R (previous FENIX insight). Of note, this is the first OAD drug to receive an indication for 3P-MACE risk reduction. Below, FENIX provides additional details on messaging across the SGLT2i class. The updated Invokana patient website indicates that “Invokana is the only type 2 diabetes pill approved to help lower your A1C and reduce the risk of major cardiovascular events including heart attack, stroke, CV death.” The updated promotion depicting a male character doing a heart sign also seems to be new…….

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

Tresiba U-100 10mL vial FDA approved

According to Drugs@FDA, Novo Nordisk has received US approval for the commercialization of a 10mL vial of Tresiba U-100. Of note, Novo has not received approval for a U-200 vial. Below FENIX provides additional details on the new vial, specifically as it pertains to pediatric use.

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

Thoughts on PIONEER-6 Results

On Friday, Novo Nordisk announced positive top-line results from the oral semaglutide CVOT, PIONEER-6. Although PIONEER-6 did not meet superiority for 3P-MACE, Novo reported statistically significant (ss) ~50% RRRs for CV death and all-cause mortality. Below, FENIX discusses the likelihood for the semaglutide franchise to receive a CV risk reduction indication in the context of the somewhat divergent PIONEER-6 results, a description of different filing scenarios against Lilly characterized as high likelihood, low likelihood, and “power move”, what an FDA adcom could look like, and finally, external factors of influence. PIONEER-6 consistency check Below is a table comparing the results……

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

Medtronic Acquires Nutrino Health

Medtronic announced plans to acquire Nutrino Health, a company focused on providing nutrition-related data services, analytics, and technologies. Recall, Medtronic has an existing relationship with Nutrino to integrate Nutrino’s FoodPrint app with the iPro2 professional CGM (previous FENIX insight). Below, FENIX provides thoughts on the acquisition and how Medtronic could leverage Nutrino’s capabilities moving forward.  With the launch of Medtronic’s Guardian Connect stand-alone CGM, the company is placing increased focus and resources toward the CGM market. As previously stated by FENIX, Medtronic is looking to create the “smart CGM” category through software-based features like Nutrino. Therefore, it makes sense for Medtronic to acquire……

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

Dexcom and Verily Update Agreement, Focus on T2DM Market

Dexcom and Verily recently announced an amendment to their collaboration and license agreement for the development of next-gen CGM systems. The updated agreement and shift in focus toward the second gen “Band-Aid-like” sensor is consistent with Dexcom senior management commentary during the Q3 ’18 earnings call. While the amendment to the agreement appears to suggest an underlying confidence in its product development, Wallstreet did not react as $DXCM has remained flat. Below, FENIX provides thoughts on the potential impact of the updated agreement on Dexcom and its competitors in the CGM market.

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

Onduo Free Promotional Program; Insulet Dash Meets ISO Standards

Onduo announced it is giving away subscriptions to its virtual diabetes program to patients in Georgia. Additionally, Insulet announced it received ISO 27001 certification for its Omnipod Dash. Below, FENIX provides insight into how Onduo could be leveraging the giveaway with payers and the impact of digital security to Insulet’s smartphone-controlled pumps. Onduo Virtual Diabetes Care According to the press release, Onduo will giveaway a 12-month subscription to its virtual diabetes care program to the first 1,000 eligible patients in Georgia. Of note, the promotion coincides with National Diabetes Awareness month.  While it remains speculation, Onduo managed care coverage in Georgia could be lagging behind the……

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

Livongo Recognized by CDC

Livongo announced the Centers for Disease Control (CDC) granted Livongo “full recognition,” which recognizes diabetes prevention programs that meet a CDC-approved curriculum for duration, intensity, and reporting requirements. “Full recognition” is part of the CDC’s National Diabetes Prevention Program. Below, FENIX provides thoughts on how Livongo will likely leverage the CDC recognition to help aid uptake for its diabetes program.  Despite the advances in diabetes-related medications, the prevalence of T2DM continues to rise, which is why organizations like the CDC have endorsed technological solutions that focus on changing patient behavior. Livongo is clearly looking to leverage the increased CDC focus on diabetes to aid……

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

Medtronic CY Q3 ’18 (FY Q2 ’19) Earnings Update

Medtronic hosted its CY Q3 ’18 (FY Q2 ’19) earnings call and provided brief updates to its diabetes device pipeline and commercial activities including the ongoing launch of its standalone CGM, Guardian Connect. Below, FENIX provides key highlights of the earnings call as well as perspective on Medtronic’s push into the standalone CGM market.

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

Verily/Novartis Halts Glucose Sensing Contact Lens Development

Verily announced it has placed a hold on the development of its glucose-sensing contact lens that it had been working on in partnership with Novartis (Alcon). The announcement comes as no surprise given comments from Novartis’s Chairman, Joerg Reinhardt, in May 2017 saying “[The glucose-sensing lens is] a long-term project, not something where we were expecting a breakthrough in the first couple of years” and “I personally think it’s a highly risky project.” Below, FENIX provides thoughts on the Verily/Novartis product as well as the future of non-invasive glucose monitoring.

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