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This week, data from Novo Nordisk’s (NVO - Free Report) early-stage study on a new weight loss pill called amycretin showed that it could be more effective than Wegovy, its popular injection for obesity. Meanwhile, the FDA approved Johnson & Johnson's (JNJ - Free Report) lung cancer medicine, Rybrevant, for first-line use. 

Additionally, Roche (RHHBY - Free Report) & Alnylam (ALNY - Free Report) announced positive data from a hypertension study on the pipeline candidate, zilebesiran. AstraZeneca’s (AZN - Free Report) two datopotamab deruxtecan applications for lung and breast cancer were validated in the EU.

Recap of the Week’s Most Important Stories - Novo Nordisk’s New Obesity Pill Tops Wegovy 

At its Capital Markets Day, Novo Nordisk presented data from a phase I study on its new oral obesity pill called amycretin. The data showed that amycretin led to a weight loss of 13.1% in users in 12 weeks compared to placebo. The drug has shown faster weight loss than Wegovy, a GLP-1 agonist, which showed a weight loss of about 5-6% in a mid-stage study.

A phase I study on oral amycretin is already complete, while a phase I study on subcutaneous amycretin is ongoing with an expected data readout in 2025.

Novo Nordisk also announced top-line data from the kidney outcomes study, called FLOW, evaluating the efficacy of its diabetes medicine, Ozempic (semaglutide), for the prevention of the progression of renal impairment in people with type II diabetes and chronic kidney disease (CKD).

The study achieved its primary endpoint by showing that semaglutide 1.0 mg led to a statistically significant and superior reduction of 24% in the risk of kidney disease-related events (kidney disease progression as well as cardiovascular and kidney death) in the above-mentioned patient group.

Based on data from the FLOW outcomes study, Novo Nordisk expects to file regulatory applications seeking label expansion for Ozempic for the CKD indication in the United States and EU in 2024.

Roche/Alnylam’s Hypertension Study Meets Main Goal

Roche and partner Alnylam’s phase II study evaluating zilebesiran, an investigational RNAi therapeutic for the treatment of hypertension or high blood pressure, met its primary endpoint. Data from the study called KARDIA-2 showed that treatment with zilebesiran plus a standard-of-care hypertension drug led to a clinically and statistically significant reduction in systolic blood pressure at month three.

Alnylam and Roche have also initiated the phase II study called KARDIA-3 to evaluate the efficacy of zilebesiran in people with uncontrolled hypertension who are at high cardiovascular risk.

FDA Approves J&J’s Rybrevant for First-Line EGFR-Mutated NSCLC

Johnson & Johnson announced that the FDA has granted approval to Rybrevant in combination with chemotherapy for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations. The approval for this expanded use of Rybrevant is based on data from the phase III PAPILLON study.

The FDA had granted accelerated approval to Rybrevant in 2021 for patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations whose disease progressed on or after platinum-based chemotherapy. PAPILLON was also a confirmatory study for this accelerated approval, and the latest FDA action converted the accelerated approval to a full approval.

AstraZeneca’s Dato-DXd Lung & Breast Cancer Applications Validated in EU

The European Medicines Agency (EMA) validated two applications seeking approval of AstraZeneca’s antibody drug conjugate, datopotamab deruxtecan (Dato-DXd), for lung and breast cancer.

While one seeks approval for locally advanced or metastatic non-squamous non-small cell lung cancer in adult patients who have received prior systemic therapy, the other looks for approval for unresectable or metastatic HR+ HER2- breast cancer.

The applications are based on data from the TROPION-Lung01 and TROPION-Breast01 phase III studies. In the United States, an application for the NSCLC indication is under review with the FDA. The FDA is expected to give its decision in the fourth quarter of 2024.

The NYSE ARCA Pharmaceutical Index rose 2.53% in the last five trading sessions.

Large-Cap Pharmaceuticals Industry Five-Year Percentage Return

Image Source: Zacks Investment Research

Here’s how the eight major stocks in the sector performed in the last five trading sessions.

In the last five trading sessions, Novo Nordisk rose the most (13.9%), while Merck declined the most (2.5%). In the past six months, Novo Nordisk has risen the most (36.8%), while Pfizer has declined the most (20.9%).

What's Next in the Pharma World?

Keep an eye out for regular pipeline and regulatory updates next week.

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