Tag Archives: Diabetes

CREDENCE Label Update for Invokana is a Big Win for Janssen

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.

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Sanofi DCV R&D Head Set to Move On

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.

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Zealand Dasiglucagon Pediatric Study Meets Primary and Secondary Endpoints

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.

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Insulet Omnipod DASH Pump Receives Interoperability Designation

Insulet announced it received FDA clearance for the “Omnipod DASH ACE Pump” to be classified as an alternate controller enabled (ACE) pump which allows for integration with other interoperable components (e.g. iCGM and eventually an “iAlgorithm” although no “iAlgorithms” are approved as of yet). Recall, ACE is FDA’s new designation for pump interoperability which requires manufacturers to meet a set of special controls. Below, FENIX provides thoughts on the Omnipod ACE pump designation including read-through to Insulet’s closed-loop developments (Omnipod Horizon and Tidepool Loop).

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AZ’s Triple FDC (Dapa/Saxa/Met) Receives Positive CHMP Opinion

AstraZeneca announced it received a positive CHMP opinion for the FDC of dapagliflozin+saxagliptin+metformin branded as “Qtrilmet.” Recall, FDA approved AZ’s triple FDC (called Qternmet XR in the US) in May 2019. Below, FENIX provides brief thoughts on the Qtrilmet positive CHMP opinion.

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Novo Hosts Post-approval Rybelsus Investor Call; Semaglutide HFpEF Study?

Novo Nordisk hosted an investor call to discuss the recent Rybelsus FDA approval (previous FENIX insight). Unsurprisingly, much of the investor call discussion centered around Rybelsus pricing and market access. Below, FENIX provides a Rybelsus pricing and website analysis as well as thoughts on Novo’s commentary regarding a potential semaglutide HFpEF study.

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Oral Semaglutide Approved as “Rybelsus”

Novo Nordisk announced FDA approval of its oral semaglutide which is now branded as “Rybelsus” (view Rybelsus US label here). Rybelsus (pronounced reb-EL-sus) appears to be a play on the word “rebel” alluding to the idea that oral semaglutide is rebelling against injectable GLP-1RA. Recall, Novo filed oral semaglutide on March 20, 2019 with a priority review voucher (PRV) which allowed for a short 6-month review. Below, FENIX provides a Rybelsus label analysis, thoughts on the impending launch, and potential insights into the upcoming CV indication PDUFAs for Ozempic and Rybelsus.

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REWIND Receives Positive CHMP Opinion

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.

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New MannKind and Dance Inhaled Insulin Data; EASD 2019 Day 4

On the fourth day of EASD, 3 key press releases were observed including new inhaled insulin data from MannKind and Dance. Additionally, Xeris announced the initiation of its Ph2 pramlintide+insulin fixed-ratio combination trial. In case you missed it earlier today, FENIX also provided coverage of Novo’s Ph3b CONCLUDE data presentation (H2H Tresiba vs. Toujeo T2DM basal-only trial). Below FENIX provides insights and context from each respective announcement.

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Thoughts on CONCLUDE (H2H Tresiba vs. Toujeo T2DM Basal-only Trial)

Novo Nordisk presented results at EASD from CONCLUDE, its Tresiba vs. Toujeo T2DM basal-only H2H study, and announced the results in a press release. While the trial failed to demonstrate a statistically significant benefit in the primary endpoint (severe or BG-confirmed symptomatic hypoglycemia), key secondary outcomes showed a clear benefit favoring Tresiba. It is a bit ironic that since the primary endpoint was not met, no conclusions can be made from the CONCLUDE secondary outcomes. Below, FENIX provides thoughts on the trial including a winners & losers analysis.

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