A Ph1 trial for a new Lilly compound (LY900027) has been observed on CT.gov. Below, FENIX provides thoughts on what the potential MOA could be particularly given the similarity in compound ID with Lilly’s ultra-rapid-acting insulin lispro (URLi), LY900014.
Today, FDA held an advisory committee meeting to discuss the benefit/risk profile of 2.5mg empagliflozin for the treatment of T1DM. Somewhat surprisingly, the panel voted overwhelmingly against (2-14) the approval of 2.5mg empa based on the currently characterized benefit/risk profile and small amount of supporting data. BI/Lilly subsequently issued a press release regarding the outcome of the adcom. Below, FENIX provides insight into the future of SGLTi therapy in T1DM including implications to BI/Lilly, AZ, and Lexicon.
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).
Janssen and Vifor Pharma announced a US commercial partnership where Vifor will promote Invokana to nephrologists based on the new CREDENCE DKD indication. Additionally, BI/Lilly disclosed plans to “modernize” their current alliance with a focus on the commercialization of Jardiance in T2DM, heart failure, and chronic kidney disease. Below, FENIX provides context and insights surrounding these announcements. Vifor to Target Nephrologists for Janssen’s Invokana Janssen announced a partnership with Vifor Pharma, a global pharmaceutical company with a focus in nephrology, iron deficiency, and cardio-renal therapies. As a part of the agreement, Vifor’s dedicated nephrology salesforce will promote Invokana to nephrologists. Janssen will……
Lilly has initiated a new Ph1 trial evaluating an unknown compound (LY3437943) vs. Trulicity in T2DM patients. Below, FENIX has conducted an analysis to help identify the compound and potential MOA.
Lilly hosted its Q3 ’19 earnings call (press release) and provided updates across its diabetes business. In a separate press release, Lilly disclosed that its current senior vice president of Lilly and president of Lilly Diabetes and Lilly USA, Enrique Conterno, will be retiring at the end of the year. Mike Mason, current SVP of Connected Care and Insulins, will succeed Conterno. During the earnings call, Lilly also highlighted Ph1 development of its triple-agonist and oral GLP-1 non-peptide agonist, Jardiance LCM, the recent positive CHMP opinion for Baqsimi, and Trulicity pricing dynamics. Below, FENIX provides context and insights from the call.
The CHMP agenda for this week’s meeting (October 14-17) has been released, and it includes two notable items (Lilly nasal glucagon opinion and Toujeo age indication extension). Below, FENIX provides diabetes-related highlights and insights from the CHMP agenda.
FDA has requested an advisory committee on November 13, 2019 to discuss the use of empagliflozin in T1DM. Of note, the empa T1DM adcom appears to be part of a 2-day adcom with Amarin’s REDUCE-IT which is scheduled for November 14. As always, FENIX will provide full coverage and analysis of the adcom. Below, FENIX provides brief thoughts on the empa T1DM adcom including hypotheses as to why the empa T1DM review has progressed to an adcom while Lexicon and AZ received CRLs for sota and dapa, respectively.
Lilly announced that CHMP issued a positive opinion for a Trulicity CV indication based on results from the REWIND CVOT. Below, FENIX provides thoughts on the impending Trulicity EU label update as well as potential readthrough to the ongoing FDA regulatory review.