📰 FDA Approves Novo Nordisk’s Alhemo for Hemophilia Treatment
Shares rise 5.4% following groundbreaking approval of once-daily prophylactic injection for hemophilia A and B with inhibitors.
Novo Nordisk’s NVO 0.00%↑ stock rose 5.4% in pre-market trading after the FDA approved Alhemo (concizumab-mtci), a once-daily subcutaneous injection for preventing bleeding episodes in patients aged 12 and older with hemophilia A or B and inhibitors. The approval follows promising results from the Phase 3 Explorer7 clinical trial, which showed an 86% reduction in bleeding events for patients using Alhemo compared to those receiving no prophylactic treatment. Alhemo works by inhibiting a protein that limits clotting, enhancing thrombin production to help prevent bleeding in patients with hemophilia.
Alhemo is a significant breakthrough, offering a first-of-its-kind subcutaneous treatment for hemophilia patients with inhibitors, who have struggled with the limitations of intravenous therapies. In the trial, patients on Alhemo showed a significantly lower annual bleeding rate—1.7 compared to 11.8 for those without prophylaxis. Moreover, 64% of patients on Alhemo experienced zero treated bleeding episodes during the first 24 weeks, compared to just 11% in the control group. With its ease of use and efficacy, Alhemo provides a new treatment option for a challenging patient population.
This approval strengthens Novo Nordisk’s position as a leader in the hemophilia space and underscores its commitment to addressing unmet medical needs. Alhemo’s success marks a major advancement in hemophilia care, offering patients greater flexibility in managing their condition and reducing the treatment burden.
Source: Novo Nordisk Investor Relations, Reuters
Disclaimer:
The information and opinions provided in this article are for informational and educational purposes only and should not be considered as investment advice or a recommendation to buy, sell, or hold any financial product, security, or asset. The Future Investors does not provide personalized investment advice and is not a licensed financial advisor. Always do your own research before making any investment decisions and consult with a qualified financial professional before making any investment decisions. Please consult the general disclaimer for more details.