Tag Archives: NOVO

New Semaglutide Formulations in Ph2 Pen Trial

A CT.gov record for a new Ph2 trial has been observed comparing FlexTouch (PDS290) to the DV3396 pen as well as two different formulations of semaglutide (“Semaglutide B” and “Semaglutide D”). Recall, in July 2019, Novo initiated a nearly identical Ph2 study evaluating two formulations of semaglutide in the same injectors. Below, FENIX provides updated insights regarding the trials, DV3396 injection device, and the new semaglutide formulations.

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Fiasp Approved for Pump Use in US

Novo Nordisk announced FDA approved Fiasp pump compatibility in adults with T1DM and T2DM. According to Novo, the updated label is based on data from the Onset 5 clinical trial (CT.gov record). Recall, Onset 5 demonstrated non inferiority in the primary outcome measure of change in A1C, but failed to show superiority. Below, FENIX provides context and insight surrounding the approval, including read-through to Lilly’s ultra rapid-acting insulin lispro (URLi).

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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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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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New Novo Insulin Savings Program

Novo Nordisk announced plans to initiate a new US insulin savings program starting on January 2, 2020. Under the new plan, Novo will offer a $99 Cash Card Program for a select volume of any of its insulin analog products as well as the launch of NovoLog and NovoLog Mix Authorized Generics (AG). Below, FENIX provides thoughts on the New Novo insulin program in the context of similar programs by Lilly and Sanofi.

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Sanofi Initiates New Toujeo vs. Tresiba T1DM CGM Study (inRange)

A CT.gov record has been observed for a new Sanofi-sponsored T1DM Ph4 Toujeo vs. Tresiba H2H non-inferiority trial utilizing CGM. Of note, the trial, called “inRange,” will evaluate time-in-range (TIR) as the primary outcome. Below, FENIX provides thoughts on this new trial in the context of the ongoing basal insulin saga between Sanofi and Novo Nordisk.

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Novo Sues Mylan Over Generic Victoza

Novo has filed a lawsuit against Mylan over Mylan’s ANDA Paragraph IV filing of a generic Victoza (view court documents here). In the complaint, Novo asserts that Mylan is infringing upon 7 Novo patents. Recall, during Novo’s Q2 ’19 earnings press release, Novo disclosed it received notice from Mylan regarding the generic Victoza ANDA filing but had not yet filed suit (previous FENIX insight). Below, FENIX provides brief thoughts on the Novo lawsuit including context from Novo’s recent settlement with Teva for its generic Victoza filing.

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New Novo Nordisk Ph1 Compound With Unknown MOA

A new Novo Nordisk Ph1 first-in-human trial for an unknown compound (NNC0385-0434) has been observed on CT.gov. According to the CT.gov record, the trial will evaluate a single subcutaneous injection of NNC0385-0434 in both healthy volunteers and in patients with hypercholesterolemia. Below, FENIX provides potential insights into the new compound.

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