Intarcia announced FDA accepted the ITCA-650 re-filing, nearly 2 years after it received a CRL. Additionally, Dexcom announced it received FDA clearance for a new G6 professional CGM. Below, FENIX provides thoughts and insights on the respective news items.
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.
A trial has been posted on CT.gov evaluating a new Medtronic extended wear infusion set (EWIS). Recall, Medtronic recently announced it had received an IDE from FDA to initiate EWIS development. Below, FENIX provides thoughts on the trial in the context of a future infusion set/CGM combination.
According to new court documents, the presiding judge in the Sanofi v. Mylan glargine lawsuit has denied Mylan’s request to rule two Lantus formulation patents invalid. The trial to settle the ongoing patent dispute is scheduled to start on December 2, 2019. Below, FENIX provides thoughts on the judge’s ruling and the potential impact on the Mylan/Biocon bs-glargine US launch timeline.
A series of diabetes-related news has come out today including Sanofi’s plan to unveil its new business strategy during an Investor Day in December. Additionally, Novo Nordisk announced a partnership with Noom for a digital obesity coaching solution, and Lifescan is engaging with Willis Towers Watson to expand access to the OneTouch Reveal Plus digital platform. Below, FENIX provides thoughts and analysis for each respective news item.
Yesterday, Janssen announced FDA approval of the Invokana renal protection indication based on results from the CREDENCE trial. Following the approval, Janssen has already updated the Invokana patient and HCP websites with CREDENCE being front and center. Below, FENIX analyzes the updated messaging and provides insights into the impending field launch for the new renal protection indication.
Senseonics announced it has completed enrollment for its trial evaluating the 180-day configuration of its Eversense implantable CGM. Recall, Senseonics’s partner, Roche, is already commercializing the 180-day system (Eversense XL) in Europe. Below, FENIX provides thoughts on how the move from a 90 to 180-day sensor may impact Eversense uptake in the US.
Janssen announced FDA approval of a new Invokana indication to reduce the risk of kidney disease, CV death, and heart failure hospitalizations in T2DM patients who have diabetic nephropathy with albuminuria. Recall, FDA granted priority review to the CREDENCE sNDA shortening the review time to 6 months. CREDENCE is the second first-pass priority review approval in a row for diabetes following Novo’s Rybelsus (oral semaglutide) on Sept 20. Below, FENIX provides thoughts on the new indication and SGLT2i market implications with special attention to the Invokana HF indication.
Earlier in September 2019, Vifor Pharma announced the appointment of Klaus Henning Jensen as the company’s new CMO and member of the executive committee starting in January 2020. Recall, Jensen joined Sanofi in 2016 as the Head of Diabetes Development and was subsequently promoted to Head of Diabetes and Cardiovascular Development in January 2019. Below, FENIX provides insights into Jensen’s departure in the context of the ongoing leadership changes within the Sanofi organization.
Zealand Pharma announced positive topline results from its pediatric dasiglucagon hypoglycemia rescue trial in pediatric patients from 6 to 17 years of age. Below, FENIX provides insights on dasiglucagon in the context of the recent Lilly Baqsimi (nasal glucagon) and Xeris (subcutaneous Gvoke) FDA approvals.