Tag Archives: Novartis

Novartis’s Entresto Marketing Under DOJ Investigation?; Inventiva’s Ph2a Lanifibranor + Empa Trial (LEGEND); Merck and Sanofi Q3 ’21 Earnings Updates; Roche and Zur Rose Group Collaboration

A series of cardiometabolic-related news items have been observed: It has been reported that Novartis received a request from DOJ regarding details about the marketing and pricing of Entresto since 2016 (view article); Inventiva announced the design of its Ph2a combination (lanifibranor+empa) trial (LEGEND) in patients with NASH and T2DM; Merck (press release; slides) and Sanofi (press release; slides) hosted their respective Q3 ’21 earnings calls; and Roche and the Zur Rose Group announced their collaboration of healthcare products and solutions. Below, FENIX provides highlights and insights for the respective news items.

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Lilly and Novartis Q3 ’21 Earnings Updates

Today, Lilly (press release; slides) and Novartis (press release; slides) hosted their Q3 ’21 earnings calls. Below, FENIX provides highlights and insights from the respective news items.

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Kerendia Trial Initiated in Non-T2DM CKD Patients (FIND-CKD); New Virtual Diabetes Platform Launched

Two cardiometabolic-related news items have been observed: Bayer announced the initiation of FIND-CKD, a Ph3 study evaluating the use of Kerendia (finerenone) in patients with non-T2DM CKD, and 9am.health announced the launch of its virtual care platform for patients with prediabetes or T2DM in addition to raising $3.7M in seed funding to scale its operations. Below, FENIX provides highlights and insights for the respective news items.

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Leqvio PDUFA Date Disclosed; Verquvo EC approval; Ph1b Trial to Delay the Onset or Progression of T1DM Meets Primary Endpoint; Novartis and J&J Q2 ’21 Earnings Updates

Four cardiometabolic-related news items have been observed: Novartis hosted its Q2 ’21 earnings call (press release; slides) and disclosed the Leqvio (inclisiran) PDUFA date is on January 1, 2022; Merck and Bayer received EC approval of vericiguat, branded as “Verquvo,” for the treatment of symptomatic chronic HF (Merck press release here and Bayer press release here); IM Therapeutics announced positive topline results from a Ph1b study evaluating IMT-002 in adults with T1DM and the HLA-DQ8 gene; and Johnson & Johnson hosted its Q2 ’21 earnings call (press release; slides). Below, FENIX provides highlights and insights from the respective news items.

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Novartis Resubmits Inclisiran NDA; Provention Bio Receives CRL for Teplizumab

Two cardiometabolic-related news items have been observed: Novartis announced the inclisiran NDA has been resubmitted to FDA and Provention Bio announced it received a CRL from FDA for the teplizumab BLA citing the need for additional data regarding PK comparability. Of note, the Provention Bio CRL did not cite any clinical deficiencies related to the efficacy and safety data packages and confirmed the acceptability of the proposed proprietary name for teplizumab, Tzield. Below, FENIX provides highlights and insights from the respective news items.

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Lilly and Novartis Q1 ’21 Earnings Updates; New Trulicity TV DTC; Provention Meets with FDA

A series of cardiometabolic-related news items have been observed: Lilly and Novartis hosted their respective Q1 ’21 earnings calls; Lilly has initiated a new Trulicity DTC campaign; and Provention Bio announced it met with FDA on April 23, 2021 to discuss the ongoing teplizumab PK comparability issue. Importantly, Lilly disclosed that SURPASS-4 has accrued all of its pre-specified CV events and the trial is scheduled to close out in May with topline results expected by the end of Q2 ’21. Recall, Lilly has previously stated SURPASS 4 is the gating factor for tirzepatide T2DM global regulatory submissions later in 2021. Below, FENIX provides highlights and insights for the respective items.

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Thoughts on Sotagliflozin HF Indication after Entresto’s PARAGON Approval

Last week, Novartis received FDA approval for expanding the Entresto label in HF beyond HFrEF (previous FENIX insight). Ahead of Lexicon’s Q4 2020 earnings later in March, FENIX provides a reminder on the recent sequence of events in HF and thoughts on how the new HF labeling for Entresto could apply to Lexicon’s SGLTi, sotagliflozin.

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Novartis Wins with Entresto PARAGON-HF FDA Approval

Novartis announced FDA has approved the Entresto sNDA based on results from the PARAGON-HF CVOT (view updated label here). For context, the new indication eliminates the qualifier of HFrEF; however, an additional statement is included, stating the benefit is most clearly evident in patients with LVEF below normal. While the updated label does not include a pure HFpEF indication, it is thought to represent the best-case scenario for Novartis. Below, FENIX provides thoughts on the new Entresto HF indication as well as implications to the evolving HF market, notably Lexicon’s sotagliflozin.

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New Novartis CV Regulatory Comments; Novartis and J&J Q4 ’20 Earnings Updates

Novartis and J&J hosted their Q4 and FY ’20 earnings calls and provided updates to their respective cardiometabolic businesses. Of note, Novartis highlighted the upcoming Q1 ’21 PDUFA date for PARAGON-HF and discussed the inclisiran CRL issued in December 2020. Novartis anticipates responding to FDA’s CRL for inclisiran in Q2 or Q3 ’21. Additionally, J&J comments on its CV/Met portfolio were limited as a majority of the call was focused on the company’s COVID-19 vaccine development. Below, FENIX provides highlights and insights for the respective news items, including thoughts on what the Entresto HFpEF indication may cover.

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