This week's data is novo nordiskNVO's early-stage study of a new weight-loss drug called amicletin showed that the drug may be more effective than Wegovy, a popular injectable obesity treatment. FDA approved J&J'sJNJ First-line drug for lung cancer treatment Librevant. Roche Ruby/alnylam ALNY announced positive data from its hypertension study for its pipeline candidate dilevesiran. AstraZenecaAZN's two datopotamab deruxtecan applications for lung cancer and breast cancer have been validated in the EU.
Recap of this week's most important stories
Novo Nordisk's New Obesity Pill Tops Wegovy:At Capital Markets Day, Novo Nordisk announced data from a Phase I study of a new oral obesity drug called amicletin. Data showed that amicretin reduced users' weight by 13.1% over 12 weeks compared to placebo. The drug showed faster weight loss than Wegovy, a GLP-1 agonist, which showed about 5-6% weight loss in mid-term trials.
A Phase I study on oral amicletine has been completed, and a Phase I study on subcutaneous amicletine is ongoing, with data readout expected in 2025.
Novo Nordisk also reported topline data from its Kidney Outcomes Study, called FLOW, which evaluated the effectiveness of its diabetes drug Ozempic (semaglutide) in preventing progression of kidney dysfunction in patients with type II diabetes and chronic kidney disease (CKD). also announced. ).
This study showed that semaglutide 1.0 mg reduced the risk of renal disease-related events (renal disease progression, cardiovascular death, and renal death) by a statistically significant 24% in the above patient groups, leading to The evaluation items were achieved. Based on data from the FLOW outcomes study, Novo Nordisk plans to submit a regulatory application seeking label expansion for Ozempic in its CKD indication in the US and EU in 2024.
Roche/Alnylam hypertension research achieves key goals:Roche and partner Alnylam have met the primary endpoint in a Phase II study evaluating dilevesiran, an investigational RNAi therapy for the treatment of hypertension. Data from the study, called KARDIA-2, showed that treatment with dilevesiran and standard-of-care hypertension medications resulted in clinically and statistically significant reductions in systolic blood pressure at three months. Alnylam and Roche have also initiated a Phase II trial, called KARDIA-3, to evaluate the efficacy of dilevesiran in patients with high cardiovascular risk and uncontrolled hypertension.
FDA approves J&J's Rybrevant for first-line EGFR-mutant NSCLC: J&J announced that the FDA has approved Rybrevant in combination with chemotherapy as a first-line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations. This approval for expanded use of Rybrevant is based on data from the Phase 3 PAPILLON study. In 2021, the FDA granted accelerated approval to Rybrevant 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 confirmation study of this accelerated approval, and the latest FDA action changed the accelerated approval to full approval.
AstraZeneca's Dato-DXd lung and breast cancer application validated in EU: The European Medicines Agency (EMA) has reviewed two applications for approval of AstraZeneca's antibody-drug conjugate datopotamab deruxtecan (Dato-DXd) for lung and breast cancer.
One is seeking approval for locally advanced or metastatic non-squamous non-small cell lung cancer in adult patients who have received prior systemic therapy, while the other is seeking approval for unresectable or metastatic HR+HER2 -Seeking approval for breast cancer. This application is based on data from the TROPION-Lung01 and TROPION-Breast01 Phase III trials. In the United States, an application for the NSCLC indication is under review by the FDA. The FDA is expected to make a decision in the fourth quarter of 2024.
The NYSE ARC Pharmaceuticals Index has gained 2.53% over the past five sessions.
Big Pharma industry 5-year return (%)
Big Pharma industry 5-year return (%)
Here is the performance of the 8 major stocks over the past 5 trading sessions:
Over the past five trading sessions, Novo Nordisk has risen the most (13.9%) and Merck has fallen the most (2.5%).
Novo Nordisk has risen the most (36.8%) and Pfizer has fallen the most (20.9%) over the past six months.
(See the latest pharma stock roundup here: FDA preferred tags for SNY, ABBV filings, CHMP preferred tags for AZN, JNJ, MRK)
What’s next for the pharmaceutical industry?
Stay tuned next week for regular pipeline and regulatory updates.
Zacks Investment Research