- Boehringer Ingelheim and Eli Lilly And Co said their diabetes drug Jardiance showed to slow the progression of chronic kidney disease.
- The companies said the EMPA-KIDNEY phase 3 trial met its primary endpoint by demonstrating a significant kidney and cardiovascular benefit for chronic kidney disease.
- In March, the trial was stopped early because an independent monitoring panel found the drug's benefit to be sufficiently clear.
- When treated with Jardiance (empagliflozin), the risk of kidney disease progression or cardiovascular death was significantly reduced by 28% vs. placebo.
- The results were announced today during the American Society of Nephrology (ASN)'s Kidney Week 2022.
- EMPA-KIDNEY trial also demonstrated a significant reduction in all-cause hospitalizations (14%) vs. placebo, one of the pre-specified key secondary confirmatory endpoints.
- The overall safety data was generally consistent with previous findings, confirming the well-established safety profile of Jardiance.
- Reductions in other key secondary endpoints of hospitalization for heart failure, cardiovascular death, or all-cause death were not statistically significant. However, the power to detect this was limited by the number of events observed.
- Organon & Co's OGN Q3 sales reached $1.54 billion, a decrease of 4% Y/Y (up 3% on constant currency), beating the consensus of $1.52 billion.
- Women's Health increased 19% and 23% ex-FX. Nexplanon (etonogestrel implant) grew 34% ex-FX, primarily driven by favorable pricing, demand uptake in the U.S., and volume growth outside the U.S.
- Continued demand for the company's fertility offerings also contributed to growth in the quarter.
- Biosimilars revenue declined 7% (4% ex-FX) primarily driven by the timing of a tender for Ontruzant (trastuzumab-dttb) in Brazil in 2021, as well as competitive pressures in Europe.
- The adjusted gross margin improved to 67.1% from 64.9%. The company reported an adjusted EBITDA of $546 million, down 11%.
- The adjusted EPS declined 16% to $1.32, better than the consensus of $1.10.
- Guidance: Organon narrowed FY22 sales guidance to $6.1-$6.2 billion from $6.1-$6.3 billion compared to the consensus of $6.18 billion.
- The company narrowed and raised the adjusted margin EBITDA to 33.5%-34.5% from 32%-34%.
- Syndax Pharmaceuticals Inc announced updated data from the Phase 1 portion of the ongoing Phase 1/2 AUGMENT-101 trial of revumenib in patients with nucleophosmin (NPM1) mutant and mixed lineage leukemia rearranged (MLLr) relapsed/refractory (R/R) acute leukemias.
- As of the March 2022 data cutoff date, sixty patients were efficacy evaluable. The overall response rate (ORR) was 53% (32/60), with a CR/CRh rate of 30% (18/60).
- There were no discontinuations due to treatment-related adverse events, and the median duration of response was 9.1 months.
- Revumenib was well-tolerated, and no new safety signals were identified in the trial.
- Across evaluable patients with mNPM1 (n=14) or MLLr (n=46) acute leukemia who received revumenib, 12 (20%) patients proceeded to stem cell transplant, ten (83%) of whom were minimal residual disease-negative.
- Nine of the 12 patients (75%) who received a stem cell transplant remained in remission, with a median follow-up of 12.3 months, and four patients experienced remission for longer than one year.
- Three patients were treated in the compassionate use setting with revumenib maintenance following stem cell transplant or non-myeloablative stem cell boost, two (67%) remaining in remission for over one year.
