This section highlights FDA-related milestones and regulatory updates for drugs developed by NewAmsterdam Pharma (NAMS).
Over the past two years, NewAmsterdam Pharma has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Obicetrapib and TANDEM. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Obicetrapib - FDA Regulatory Timeline and Events
Obicetrapib is a drug developed by NewAmsterdam Pharma for the following indication: CETP inhibitor.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Obicetrapib
- Announced Date:
- June 9, 2025
- Indication:
- CETP inhibitor
Announcement
NewAmsterdam Pharma Company N.V. announced positive topline data from prespecified Alzheimer's Disease ("AD") biomarker analyses in the Phase 3 BROADWAY clinical trial (NCT05142722).
AI Summary
NewAmsterdam Pharma Company N.V. announced positive topline results from its Alzheimer’s Disease biomarker analysis in the Phase 3 BROADWAY trial. The prespecified sub-study showed that obicetrapib treatment led to statistically significant reductions in the primary AD biomarker, p-tau217, over a 12‐month period. This reduction was evident both in the overall study population (p<0.002) and among patients carrying the ApoE4 gene (p=0.0215). These findings support the emerging link between CETP inhibition and the prevention of Alzheimer’s pathology. The data suggest that obicetrapib, already recognized for its cardiovascular benefits by significantly lowering LDL-C levels, might also help delay or prevent the progression of Alzheimer’s disease. NewAmsterdam plans to share the full AD sub-study results at the Alzheimer’s Association International Conference in Toronto in July 2025.
Read Announcement- Drug:
- Obicetrapib
- Announced Date:
- December 16, 2024
- Indication:
- CETP inhibitor
Announcement
Menarini Group today announces positive topline data from the Phase 3 BROADWAY (NCT05142722) and the Phase 3 TANDEM (NCT06005597) clinical trials sponsored by NewAmsterdam Pharma Company N.V.
AI Summary
Menarini Group announced positive topline results from the Phase 3 BROADWAY (NCT05142722) and TANDEM (NCT06005597) clinical trials sponsored by NewAmsterdam Pharma Company N.V. In the BROADWAY study, patients receiving 10 mg Obicetrapib achieved a statistically significant 33% reduction in LDL-C (p<0.0001) compared to placebo, with about half reaching an LDL-C level below 55 mg/dL. Additionally, a 21% reduction in major adverse cardiovascular events was observed at one year, favoring Obicetrapib. In the TANDEM trial, the fixed-dose combination of Obicetrapib with Ezetimibe showed even greater efficacy, with over 70% of patients achieving the LDL-C target and an LS mean reduction of 48.6% versus placebo (p<0.0001). Both studies demonstrated that the therapies were well tolerated, marking a promising opportunity for improved cardiovascular outcomes in patients struggling with elevated LDL-C levels.
Read Announcement- Drug:
- Obicetrapib
- Announced Date:
- December 10, 2024
- Indication:
- CETP inhibitor
Announcement
NewAmsterdam Pharma Announced Topline Data From Phase 3 BROADWAY Trial Of Obicetrapib For Atherosclerotic Cardiovascular Disease And/Or Heterozygous Familial Hypercholesterolemia
AI Summary
NewAmsterdam Pharma announced positive topline results from its Phase 3 BROADWAY trial that evaluated obicetrapib in adults with established atherosclerotic cardiovascular disease and/or heterozygous familial hypercholesterolemia. The trial met its primary endpoint, showing a statistically significant 33% reduction in LDL-C levels compared to placebo after 84 days, even when patients were already on maximally tolerated lipid-lowering therapies. In addition to improving LDL-C, the trial observed a 21% reduction in major adverse cardiovascular events at one year. Obicetrapib, taken as a once-daily low-dose tablet, was well-tolerated with a safety profile comparable to placebo, and early results suggest its potential benefits may extend beyond simple LDL-C lowering. NewAmsterdam Pharma plans to share further data and discuss potential filings with regulatory authorities in upcoming scientific sessions.
Read Announcement- Drug:
- Obicetrapib
- Announced Date:
- November 18, 2024
- Indication:
- CETP inhibitor
Announcement
NewAmsterdam Pharma Company N.V announced additional results from the Company's Phase 3 BROOKLYN clinical trial (NCT05425745) evaluating obicetrapib in adult patients with heterozygous familial hypercholesterolemia ("HeFH"), whose LDL-C is not adequately controlled, despite being on maximally tolerated lipid-lowering therapy.
AI Summary
NewAmsterdam Pharma announced additional results from its Phase 3 BROOKLYN trial evaluating obicetrapib in adults with heterozygous familial hypercholesterolemia (HeFH) whose LDL-C remains high despite maximum lipid-lowering therapy. The study met its primary endpoint, showing a 36.3% reduction in LDL-C at day 84 and a 41.5% reduction at day 365 compared to placebo. Obicetrapib also significantly lowered lipoprotein(a) with reductions of 45.9% at day 84 and 54.3% at day 365, along with meaningful decreases in both total and small LDL particles. The drug was well tolerated, with safety results comparable to placebo and no increases in blood pressure. These findings suggest that obicetrapib may offer a promising new option for patients with HeFH who continue to struggle with elevated LDL-C levels despite existing therapies.
Read Announcement- Drug:
- Obicetrapib
- Announced Date:
- July 29, 2024
- Indication:
- CETP inhibitor
Announcement
NewAmsterdam Pharma Company N.V. announced positive topline data from the Company's Phase 3 BROOKLYN clinical trial (NCT05425745).
AI Summary
NewAmsterdam Pharma Company N.V. announced positive topline results from its Phase 3 BROOKLYN clinical trial (NCT05425745). The study evaluated obicetrapib, an oral CETP inhibitor, in adult patients with heterozygous familial hypercholesterolemia (HeFH) whose LDL-C levels were not well-controlled, even with maximal lipid-lowering therapy. The primary endpoint was met, showing a statistically significant reduction (p<0.0001) in LDL-C levels. Obicetrapib lowered LDL-C by 36.3% at week 12 and 41.5% at week 52 when compared with placebo. The treatment was well-tolerated, with similar safety results to placebo and no increase in blood pressure. These promising outcomes suggest that obicetrapib could offer a new, effective oral option for patients with HeFH, potentially changing the way high cholesterol is managed in this challenging patient group.
Read Announcement
TANDEM - FDA Regulatory Timeline and Events
TANDEM is a drug developed by NewAmsterdam Pharma for the following indication: In Patients with ASCVD or ASCVD Risk Factors and/or HeFH.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- TANDEM
- Announced Date:
- November 20, 2024
- Indication:
- In Patients with ASCVD or ASCVD Risk Factors and/or HeFH
Announcement
NewAmsterdam Pharma Company N.V. announced positive topline data from the Company's Phase 3 TANDEM clinical trial (NCT06005597). TANDEM will support global regulatory filings for the 10 mg obicetrapib and 10 mg ezetimibe fixed-dose combination in adult patients with heterozygous familial hypercholesterolemia ("HeFH") and/or atherosclerotic cardiovascular disease ("ASCVD") or multiple ASCVD risk factors, whose LDL-C is not adequately controlled, despite being on maximally tolerated lipid-lowering therapy.
AI Summary
NewAmsterdam Pharma Company N.V. announced positive topline results from its Phase 3 TANDEM clinical trial (NCT06005597), supporting global regulatory filings for its fixed-dose combination treatment. The trial evaluated a once-daily oral tablet containing 10 mg obicetrapib combined with 10 mg ezetimibe in adult patients with heterozygous familial hypercholesterolemia (HeFH) and/or atherosclerotic cardiovascular disease (ASCVD) or multiple ASCVD risk factors, whose LDL-C remains elevated despite maximally tolerated lipid-lowering therapy.
The TANDEM study met all co-primary endpoints, showing statistically significant LDL-C reductions, with the combination therapy lowering LDL-C by approximately 50% at day 84 compared to placebo. Over 70% of patients on the combination achieved LDL-C levels under 55 mg/dL. The treatment was well tolerated with a safety profile consistent with previous studies, underscoring its potential as a new treatment option for patients at risk of cardiovascular events.
Read Announcement
