Today, Lilly (press release; slides) and Novartis (press release; slides) hosted their Q3 ’21 earnings calls. Below, FENIX provides highlights and insights from the respective news items.
Two cardiometabolic-related news items have been observed: AstraZeneca’s Forxiga received a positive CHMP opinion to include treatment of children aged 10 years and older with T2DM; and generic sitagliptin received a positive CHMP opinion. Below, FENIX provides highlights and insights for the respective news items.
Two diabetes-related news items have been observed: vTv Therapeutics announced positive results of TTP399 mechanistic study in patients with T1DM; Innovation Zed announced research advancements for its non-invasive CGM project. Below, FENIX provides further highlights and insights for the respective news items.
The CHMP agenda for this month (October 11-14) has been released, and it includes two notable items, BI/Lilly has filed the Jardiance HFpEF indication and an opinion for generic sitagliptin (EMEA/H/C/005741) is up for adoption. Below, FENIX provides highlights and insights from the October 2021 CHMP agenda.
Three cardiometabolic-related news items have been observed: BI/Lilly announced the launch of an educational initiative for HCPs, called CRMSynced, which uses gamification to encourage HCPs to prioritize a holistic approach to disease management; MannKind announced the first patient has been enrolled in the Afrezza Ph3 pediatric study; Teatis announced the launch of Teatis RD on Demand, a resource designed to connect people with diabetes to dietitians who can assist in managing their disease through personalized meal plans. Below, FENIX provides highlights and insights for the respective new items.
A series of cardiometabolic-related news items have been observed: the CHMP agenda for this month (September 13-16) has been released; iRhythm announced Quentin Blackford, outgoing Dexcom COO, will join the company as President and CEO, effective October 4, 2021; and Provention Bio issued an update on the BLA resubmission of teplizumab to delay the onset of T1DM in at-risk individuals (press release). Below, FENIX provides highlights and insights from the respective news items.
A series of cardiometabolic-related news items have been observed: BI/Lilly announced FDA granted Breakthrough Therapy Designation (BTD) to Jardiance for the treatment of HFpEF; Metacrine announced the Ph2a trial evaluating MET642 in 180 patients with NASH has completed enrollment; and Dario Health announced it was selected as the digital health provider for a Northeast regional employer. Below, FENIX provides highlights and insights for the respective news items.
Today, BI/Lilly presented positive full results from EMPEROR-Preserved, the heart failure outcomes trial (HFOT) for Jardiance in HFpEF. While the 21% relative risk reduction augmented the clinical utility of SGLT2i in HF, the lack of benefit in patients with a LVEF ≥60% was very surprising and opens up a multitude of implications and opportunities across CV medicine. Below, FENIX provides highlights, insights, and implications from EMPEROR-Preserved that are sure to make 2022 another dynamic year for the CV global landscape.
Two cardiometabolic-related news items have been observed: Lexicon announced the presentation of additional analyses from the SOLOIST and SCORED Ph3 trials at the ESC 2021 Digital Experience; and Amarin announced the on-demand, Late Breaking Science Presentation at ESC 2021 of data from the prior MI subgroup analysis of its Vascepa/Vazkepa (icosapent ethyl) Ph3 REDUCE-IT study. Of note, the full ESC 2021 conference takes place August 27-30. Below, FENIX provides highlights and insights for the respective news items.
Last week, FDA approved Jardiance for the treatment of HFrEF (view updated Jardiance label here; previous FENIX insight). The approval was based on results from the EMPEROR-Reduced CVOT which was first presented at ESC 2020; previous FENIX insight). As a reminder, BI/Lilly will be presenting full results from EMPEROR-Preserved as a Hot Line session at ESC 2021 on August 27 at 11:25AM ET (view ESC session). Recall, in July 2021, BI/Lilly announced positive topline results from the Ph3 EMPEROR-Preserved trial, but it did not provide any information on the magnitude of effect (previous FENIX insight). Below, FENIX provides thoughts on the new Jardiance HFrEF indication, including a favors/disfavors analysis for the HF market.