Category Archives: Bolus Insulin

Fiasp Pediatric Indication Filed in US and EU

Novo Nordisk announced it has submitted EMA and FDA applications for the use of Fiasp in adolescents and pediatrics based on results from the Onset 7 study (children down to age 1). According to the press release, Novo anticipates a response from EMA later in 2019 and an FDA decision in “early 2020.” Below, FENIX provides insight into the Fiasp pediatric filings as well as context from Lilly’s upcoming URLi pediatric study (Pronto-Peds).

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Diabetes Takes a Backseat During Part II Drug Pricing Hearing

Today, the Senate Finance Committee held the second drug pricing hearing of 2019 (Drug Pricing in America: A Prescription for Change, Part II). Part I was held on January 29, 2019. While the Part I drug pricing hearing spent much time discussing insulin pricing, diabetes-specifically was hardly mentioned. When a specific drug was mentioned, it was most often AbbVie’s Humira. Below, FENIX provides diabetes-related highlights and insights from the hearing.

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MannKind Q4 ’18 Earnings Update

MannKind hosted its Q4 ’18 earnings call and provided updates to its Afrezza business including commercial and clinical activities. Below are highlights and insights from the call.

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Thoughts on New Hygieia d-Nav Mobile App for Insulin Titration; New Data published in The Lancet

Hygieia recently announced it received 510(k) clearance for a mobile app that is part of the company’s d-Nav insulin guidance service. Recall, d-Nav is a T2DM-focused, cloud platform that provides personalized insulin dose recommendations based on the user’s BGM values. Additionally, results were published in The Lancet for a study showing d-Nav plus HCP support led to superior glycemic control than with HCP support alone. Below, FENIX provides thoughts on how Hygieia’s d-Nav and other similar systems could impact the diabetes market.

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New Lilly and Novo uRAI pump trials: URLi ‘PRONTO-Pump-2’ and Fiasp in iLet Bionic Pancreas

Recently, FENIX has observed new Lilly and Novo pump trials on CT.gov. Lilly has posted a Ph3 trial for its ultra-rapid-acting insulin lispro (LY900014; URLi) for pumps in adults with T1DM called ‘PRONTO-Pump-2.’ Additionally, Novo has initiated a new Ph2 trial for Fiasp in an iLet Bionic Pancreas. Below, FENIX provides thoughts on the respective studies.

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Sanofi Discontinues 2 Dual-Agonist Programs; Q4 ’18 Earnings Update

Today, Sanofi hosted its Q4 ’19 earnings call, provided updates to its diabetes business, and disclosed that it discontinued SAR425899 (GLP-1/GCGR) and SAR438335 (GLP-1/GIP) for the treatment of obesity in T2DM and T2DM, respectively. Of note, Sanofi’s CEO will be testifying at the February 26, 2019 Senate Committee hearing on drug pricing. Below, FENIX provides highlights from the call as well as thoughts on Sanofi’s position in diabetes, obesity, and NASH.

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No REWIND PRV Mentioned; Lilly Q4 ’18 Earnings Update

Lilly hosted its Q4 ’18 earnings call and provided brief updates to its diabetes business including its REWIND outlook, Jardiance tailwinds, URLi regulatory filing, and CAROLINA topline results. Of note, Lilly discontinued development of the Ph2 DACRA-042 compound from KeyBioscience. Below, FENIX provides highlights and analysis from the call.

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Novo to File Oral Sema with PRV; Q4 ’18 Earnings Update

Novo Nordisk hosted its Q4 ’18 earnings call and disclosed that it will use its priority review voucher (PRV) for the oral semaglutide US filing by the end of Q1 ’18. Of note, Novo is planning to file for Ozempic and oral semaglutide CV indications based on the results from SUSTAIN 6 and PIONEER 6 despite PIONEER 6 not achieving statistical significance for 3P-MACE. Below, FENIX provides highlights from the earnings call, additional insight on the semaglutide regulatory strategy, and thoughts on why Novo likely wants an oral semaglutide adcom.

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Lilly Repeatedly Called Out During US Senate Hearing on Drug Pricing

Today, the Senate Finance Committee held the first hearing of 2019 and it highlighted US drug pricing (Drug Pricing in America: A Prescription for Change, Part I). A majority of the 3-hour discussion focused on Medicare Part B and D, Medicaid best pricing, 340B incentives, and diabetes insulin pricing in particular. Of note, when insulin was discussed, it was largely in the context of Lilly and Humalog with no mention of Novo or Sanofi. Below, FENIX provides diabetes-related highlights from the hearing and thoughts on the national discussion on drug pricing.

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Biocon CY Q4 ’18 (FY Q3 ’19) Earnings Update

Biocon hosted its CY Q4 ’18 (FY Q3 ’19) earnings call and briefly discussed its biosimilar insulin program including bs-glargine and rh-insulin. Below, FENIX provides highlights from the call as well as additional perspective on Mylan’s upcoming bs-glargine commercialization following the 30-month stay (March 2020).

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