BI/Lilly announced the initiation of a new Jardiance study (EMPULSE) in T2DM and non-T2DM patients who have been hospitalized for acute heart failure. Below, FENIX provides an overview of the trial as well as insights into how the EMPULSE trial appears to be a natural progression of BI/Lilly’s Jardiance LCM strategy.
Briefing documents for the BI/Lilly empagliflozin T1DM FDA adcom were posted today in advance of the November 13, 2019 meeting. Interestingly, BI/Lilly is only pursuing approval for the low, 2.5mg dose of empagliflozin, which demonstrated less DKA but also lower efficacy. Questions around the 2.5mg dose and its limited clinical data are likely to be the center of the adcom discussion. Below, FENIX provides thoughts on the empa T1DM adcom including analysis of the benefit/risk ratio, proposed risk mitigation strategy, and adcom panelists (9 of whom were also on the sota adcom).
A report has been published on the FDA MAUDE database indicating a patient using Tandem’s t:slim X2 insulin pump with Basal IQ technology passed away on October 3, 2019. However, in an emailed statement to media outlets, Tandem said the t:slim X2 pump with Basal IQ was not involved in the patient’s death. Below, FENIX provides context and insight related to this news including potential read-through to the impending Control IQ approval.
Lexicon hosted its Q3 ’19 earnings call and provided an update on the sotagliflozin T1DM regulatory situation as well as the T2DM Ph3 development program. Of note, Lexicon disclosed it has disputed the sota T1DM CRL with the Office of New Drugs, and it is awaiting a decision shortly. Additionally, Xeris released its Q3 ’19 earnings, and Dexcom stock has jumped +30% following its earnings beat. Below, FENIX provides insights on the sotagliflozin dispute including analysis of Peter Stein’s involvement in the Office of New Drugs review.
Dexcom and Livongo hosted their Q3 ’19 earnings calls and provided updates to their respective businesses. Below, FENIX provides highlights and insights from the respective earnings calls.
MannKind hosted its Q3 ’19 earnings call and provided updates to its diabetes business. Of note, MannKind disclosed a new, three-pronged strategy to drive Afrezza adoption. Below, FENIX provides highlights and insights from the call.
Insulet hosted its Q3 ’19 earnings call and provided updates to its Omnipod business including the ongoing launch of Omnipod Dash as well as the development of the Omnipod Horizon hybrid closed-loop system. Below, FENIX provides highlights and insights from the call.
WaveForm, a subsidiary of AgaMatrix, announced it received CE Mark for its Cascade CGM system. Importantly, WaveForm also provided insight into its plans for US commercialization. Additionally, Senseonics recently initiated a voluntary recall on some of its Eversense implantable CGMs. Below, FENIX provides thoughts on the new CGM market entrant and the potential commercial outlook.
Mylan and Becton Dickinson hosted their respective Q3 ’19 earnings calls. Of note, Mylan provided a brief update on its insulin development program (in partnership with Biocon). Below, FENIX provides diabetes-related highlights and insights from the calls.
Tandem Diabetes Care hosted its Q3 ’19 earnings call and provided updates to its diabetes business including the regulatory status of t:slim X2 with Control IQ (hybrid closed loop) and development status of its t:sport. Below, FENIX provides highlights and insights from the call.