A series of CVRM-related news items have been observed at AHA 2023 from Roche/Alnylam, Amgen, Amarin, Esperion, Lexicon, and Cleerly. Below, FENIX provides highlights and insights into the respective news items.
Novo Nordisk hosted a post-SELECT data readout investor event during AHA 2023 (view webcast). During the call, Novo reviewed the full SELECT results and provided additional commentary on the data. In case you missed it, FENIX recently conducted an analysis on the SELECT market implications (view here). Below, FENIX provides highlights and insights from the Novo AHA 2023 investor event.
Novo Nordisk announced positive full results from the SELECT CVOT (view CT.gov record) demonstrating a -20% RRR in 3P-MACE for non-T2DM people with established CVD who were treated with QW 2.4mg semaglutide (Wegovy). The full results were presented at AHA 2023 and simultaneously published in the NEJM (view publication). Recall, SELECT was filed with US and EU regulators in September and October 2023, respectively, and FDA has granted priority review with a PDUFA date projected in March 2024 (previous FENIX insight). Below, FENIX provides thoughts on the SELECT results, including potential readthrough to Lilly and other manufacturers looking to enter the obesity market.
A series of cardiometabolic-related news items have been observed from Lilly, Novo Nordisk, Madrigal, Akero, Boston Pharmaceuticals, and Smart Meter. Below, FENIX provides highlights and insights into the respective news items.
A series of cardiometabolic-related news items have been observed from Novo Nordisk, Lilly, Zealand, Lexicon, Senseonics, Xeris, and Bayer. Below, FENIX provides highlights and insights into the respective news items.
AstraZeneca hosted its Q3 ’23 earnings call (press release; slides) and provided updates to its CVRM business, including insight on its newly acquired oral GLP-1RA. Just prior to the earnings release, AZ announced it entered into an exclusive licensing agreement for ECC5004, a QD oral GLP-1RA, from Eccogene (view press release). Below, FENIX provides highlights and insights from the call, including thoughts on AZ’s decision to acquire the new oral GLP-1RA.
A series of cardiometabolic-related news items have been observed from OrsoBio, Diamyd, Esperion, Altimmune, MannKind, and Viatris. Below, FENIX provides highlights and insights into the respective news items.
Lilly announced that FDA approved tirzepatide as “Zepbound” for adults with obesity or overweight that also have weight-related comorbidities such as hypertension, dyslipidemia, T2DM, OSA, or CVD (view label). Of note, FDA also made an announcement regarding the approval (view here). Tirzepatide remains under review in the EU, UK, China, and other markets. Lilly stated Zepbound is anticipated to be launched in the US by EOY 2023 in six doses (2.5mg, 5mg, 7.5mg, 10mg, 12.5mg, and 15mg). In the press release, Lilly specifically disclosed the Zepbound WAC price of $1,059.87, which Lilly noted is 20% less expensive than Wegovy. FENIX will conduct a full label analysis of Zepbound in the coming days.
A series of cardiometabolic-related news items have been observed from Boehringer Ingelheim, Madrigal, Vertex, MannKind, and EMA. Below, FENIX provides highlights and insights into the respective news items.
A series of cardiometabolic-related news items have been observed from Novo Nordisk, Terns, Ionis, Regeneron, and Dario. Below, FENIX provides highlights and insights into the respective news items.