Humanigen (Nasdaq: HGEN) announces that lenzilumab is now available for specific hospitalized COVID-19 patients through the LenzMAP™ Managed Access Program, managed by Clinigen Group. This investigational product is accessible in 17 countries, including the UK and various European nations. The program will provide lenzilumab to patients deemed appropriate by healthcare professionals where local regulations permit. As Humanigen continues to pursue regulatory approvals for lenzilumab, the partnership with Clinigen aims to facilitate access to treatment for those in need.
Humanigen has partnered with Clinigen Group to launch a Managed Access Program (LenzMAP) for their investigational treatment, lenzilumab, aimed at hospitalized COVID-19 patients across 16 European countries. The program allows access on a case-by-case basis where no alternatives are available. Currently, lenzilumab is not authorized in any country, and Humanigen continues to pursue regulatory approvals, including a Marketing Authorization Application with the European Medicines Agency.
Secura Bio announced a distribution agreement with Clinigen Group for COPIKTRA (duvelisib) across 39 European countries, including Germany and the UK, where Secura will promote it directly. COPIKTRA, approved by the European Medicines Agency in May 2021, treats relapsed or refractory Chronic Lymphocytic Leukemia (CLL) and Follicular Lymphoma (FL). The partnership aims to ensure rapid availability and access to this oncology therapeutic for patients in need. Secura Bio is working on reimbursement and commercial launch strategies for the drug in Europe.