Lexicon hosted its Q1 ’19 earnings call and briefly discussed the ongoing US regulatory situation for sotagliflozin following the March 22, 2019 CRL. Below, FENIX provides highlights and insights from the call including thoughts on the T2DM submission and approval timeline.

Sanofi and Lexicon announced they received EU marketing authorization for the commercialization of Zynquista (sotagliflozin) in T1DM (200mg and 400mg doses). Recall, on February 28, 2019, CHMP adopted a positive opinion. Zynquista is now the second SGLTi to be approved by EU regulatory authorities. On March 25, 2019, Forxiga was granted approval. Below, FENIX provides brief thoughts on the approval.

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.

Janssen announced it has filed an sNDA for the Invokana renal outcomes study, CREDENCE. Full results from CREDENCE are scheduled to be presented on April 14 at the World Congress of Nephrology meeting. Recall, on July 16, 2018, Janssen announced that CREDENCE stopped early for positive efficacy findings. Of note, Janssen’s press release did not state whether the company requested a priority review by FDA. Below, FENIX provides thoughts on the CREDENCE filing and potential approval timelines based on whether or not FDA grants priority review.

AstraZeneca announced the European Commission (EC) approved Forxiga in T1DM. The news follows the positive CHMP opinion on February 1, 2019. Recall, Lexicon/Sanofi’s sotagliflozin also received a positive CHMP opinion on March 1, 2019 followed by a CRL from FDA on March 22, 2019. Below, FENIX provides thoughts on the Forxiga EU approval and readthrough to sotagliflozin and Jardiance.