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Global new Drug R&D express: NGM Bio's aldafermin,Roche’s Vabysmo,AstraZeneca's dapagliflozin

1. NGM Bio Announces Presentation of Data from Phase 2 Investigator-Sponsored Trial of Aldafermin for the Treatment of Patients with Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D) and Bile Acid Malabsorption (BAM) at Digestive Disease Week 2023

NGM Bio announced the results of a Phase 2 trial (NCT05130047) of aldafermin for the treatment of patients with diarrhea-predominant irritable bowel syndrome (IBS-D) and bile acid malabsorption (BAM). Adafermin-treated patients demonstrated a statistically significant decrease in serum 7αC4 at days 14 and 28 compared to placebo (p<0.001 vs placebo for both time points). Patients treated with aldafermin also had significantly decreased fecal total bile acids at days 14 and 28 compared to placebo (p=0.002 and p<0.001 respectively). There was numerically improved stool consistency in patients on aldafermin over time, particularly in week 4 of treatment, compared to placebo (p=0.047).

2. FDA accepts application for Roche’s Vabysmo for the treatment of retinal vein occlusion (RVO)

Roche announced the U.S. FDA has accepted the sBLA for faricimab for the treatment of macular edema following retinal vein occlusion (RVO). The sBLA is based on results from the phase III BALATON and COMINO studies that demonstrated treatment with faricimab provided early and sustained improvement in vision, meeting the primary endpoint of non-inferior visual acuity gains at 24 weeks compared to aflibercept.

3. Farxiga extended in the US to reduce risk of cardiovascular death and hospitalization for heart failure to a broader range of patients

AstraZeneca announced the U.S. FDA approved of dapagliflozin for the reduction of the risk of cardiovascular (CV) death, hospitalization for heart failure (hHF) and urgent heart failure (HF) visits in adults with HF. The approval was based on positive results from the DELIVER Phase III trial, which showed dapagliflozin reached a statistically significant and clinically meaningful early reduction in the primary composite endpoint of CV death or worsening HF in patients with HF with HFmrEF or HFpE.

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