A series of cardiometabolic-related news items have been observed from Zealand Pharma, Lilly, Alnylam Pharmaceuticals, and Boehringer Ingelheim. Below, FENIX provides highlights and insights for the respective news items.
A series of cardiometabolic-related news items have been observed from Sibionics, Silence Therapeutics, Lilly, Tandem, Amarin, Lexicon, Dario, Abbott, Insulet, and BI/Lilly. Below, FENIX provides highlights and insights into the respective news items.
A series of cardiometabolic-related news items have been observed from BI/Lilly, Abbott, Insulet, and Lilly. Below, FENIX provides highlights and insights into the respective news items.
Four cardiometabolic-related news items have been observed: The Wegovy US label has been updated to include 1.7mg as a second maintenance dose in addition to the 2.4mg dose (view label); BI/Lilly announced the European Commission (EC) approved Jardiance for the treatment of adults with CKD (view press release); Glucotrack announced positive results from the feasibility study for its implantable CGM (view press release); and Fibrogen announced the resignation of Enrique Conterno, with Thane Wettig taking over as interim CEO (view press release). Below, FENIX provides highlights and insights on the respective news items, including insight into Novo’s potential rationale for adding another Wegovy maintenance dose.
On the first day of ADA 2023, two cardiometabolic-related news items were observed from BI/Lilly and Intercept. Below, FENIX provides context and analysis for the announcements.
Four cardiometabolic-related news items have been observed: Novo Nordisk announced it is taking legal actions over third-party semaglutide promotion (view press release); Versanis Bio announced it completed enrollment for the global Ph2b BELIEVE study evaluating the safety and efficacy of bimagrumab as a monotherapy and in combination with semaglutide in participants with obesity (view CT.gov record); FDA approved Jardiance and Synjardy to improve glycemic control in children 10 years of age and older with T2DM (view press release) as well as Agepha Pharma’s Lodoco in adult patients with established ASCVD or with multiple risk factors for cardiovascular disease (view press release). Below, FENIX provides highlights and insights into the respective news items, including brief thoughts on the bimagrumab + semaglutide program.
Earlier this week, FDA approved Farxiga (dapagliflozin) to reduce the risk of CV death, hospitalization for HF, and urgent HF visit in adults with HF, regardless of baseline LVEF (view updated Farxiga label; previous FENIX insight). The label extension was based on positive results from the Ph3 DELIVER trial (view CT.gov record). Recall, in February 2023, Forxiga received EU approval for the expanded HF indication (previous FENIX insight). Below, FENIX has conducted a Farxiga HF label analysis in the context of the Jardiance HF indication.
A series of cardiometabolic-related news items have been observed: BI/Lilly announced FDA accepted the Jardiance (empagliflozin) pediatric T2DM sNDA (view press release); Provention Bio initiated a Ph4 open-label trial evaluating the safety and PK of teplizumab in participants with Stage 2 T1DM who are <8 years of age (PETITE-T1D; view CT.gov record); Sernova announced the first two patients in the second cohort of its US Ph1/2 clinical trial received their first islet transplant (view press release); and Xeris (press release) and vTv Therapeutics (press release) released their Q4 ’22 earnings. Below, FENIX provides highlights and insights from the respective news items.
A series of cardiometabolic-related news items have been observed from Esperion, Abbott, Lexicon, Merck, and BI/Lilly. Below, FENIX provides highlights and insights into the respective news items.
BI/Lilly announced FDA accepted the Jardiance (empagliflozin) sNDA for the treatment of adults with CKD. According to the press release, the sNDA is based on results from the Ph3 EMPA-KIDNEY trial which demonstrated Jardiance significantly reduced the risk of kidney disease progression or CV death in adults with CKD (view CT.gov record; previous FENIX insight). Below, FENIX provides brief thoughts regarding the EMPA-KIDNEY sNDA filing and the projected PDUFA date.