Sanofi hosted its Q1 ’19 earnings call but only briefly discussed its diabetes business including the recent sotagliflozin T1DM CRL. Below, FENIX provides highlights and insights from the call.
AstraZeneca hosted its Q1 ’19 earnings call and provided updates to its diabetes business. Of note, senior management disclosed that its Farxiga CVOT (DECLARE) filings have been accepted by US and EU regulatory authorities with approvals projected in 2020. Additionally, AZ said its Farxiga HF study (Dapa-HF) is projected to read out ahead of schedule (now in H2 ’19; previously 2020). Below, FENIX provides highlights and insights from the Q1 ’19 earnings call.
Curiously, there has been no news from Lilly regarding the US regulatory status of its Locemia nasal glucagon product. Recall, during Lilly’s Q2 ’18 earnings, the company disclosed that it filed the nasal glucagon with FDA in Q2 ’18 (and July in EU). Assuming a 10-month review period, approval was projected by the end of April 2019. Below, FENIX provides thoughts on the Lilly nasal glucagon regulatory situation including the possibility that Lilly received a CRL from FDA.
A CT.gov record for Novo’s oral semaglutide CVOT, SOUL, has been observed. Novo recently announced the simultaneous filings for oral semaglutide T2DM glycemic control, oral semaglutide CV risk reduction, and Ozempic CV risk reduction. Below, FENIX provides a comparative GLP-1RA CVOT analysis as well as key considerations for the SOUL trial.
Abbott and Roche hosted their respective Q1 ’19 earnings calls and provided brief updates to their diabetes businesses. Of note, Abbott disclosed its Libre 2 US filing includes a request for iCGM designation. Below, FENIX provides highlights and insights from the calls.
JnJ hosted its Q1 ’19 earnings call and provided a brief update to its diabetes business including the recent sNDA filing of the CREDENCE data for Invokana. Recall, the full CREDENCE results were presented at the World Congress of Nephrology on April 14, 2019. Below, FENIX provides a summary and insights from the call.
Yesterday, Janssen presented full results from the Invokana renal outcomes study, CREDENCE, at the World Congress of Nephrology and simultaneously published the results in the NEJM. The CREDENCE study demonstrated a 30% RRR in the primary composite endpoint (progression to end-stage kidney disease (ESKD), doubling of serum creatinine, and renal or CV death) and met all key secondary endpoints. Recall, in July 2018, CREDENCE was stopped early and Janssen subsequently announced it submitted an sNDA in late March 2019. Below, FENIX provides an overview of the full CREDENCE results, market implications, and the potential impact on ADA and AACE guidelines.
According to Drugs@FDA, the Ozempic US label has been updated to reflect a new 3mL pen offering for a maintenance dose of 1mg. The new pen has a different NDC (0169-4130-13) and dials 4 doses of 1mg each. The new pen represents a total strength of 4 mg/3 mL and harmonizes the maximum pen strength offered in Europe. Below, FENIX provides thoughts on this new pen offering including potential reasons around manufacturing efficiencies.
Sanofi announced that it has increased the benefits to its Valyou insulin savings program to now offer up to 10 boxes of SoloStar insulin pens and/or 10 vials of 10mL insulin for $99 per month. Previously each 10 mL vial was $99 and each box of SoloStar pens was $149. According to the press release, the program covers all Sanofi insulins (Lantus, Toujeo, Admelog, and Apidra) but not Soliqua. The program will become available starting in June 2019. Below, FENIX provides brief thoughts on the program in the context of the ongoing drug pricing debate.
JDRF has appointed Aaron Kowalski (pictured below, Twitter @aaronjkowalski) as the new President and CEO. Previously, Kowalski served as the Chief Mission Officer. He is succeeding Derek Rapp who stepped down in October 2018 after serving as CEO for ~5 years. Below, FENIX provides brief thoughts on Kowalski’s appointment.