Humanigen Inc., a biopharmaceutical company focused on treating and preventing an uncontrollable inflammatory response by the immune system known as “cytokine storm,” confirmed that lenzilumab is accessible now through its recently introduced Managed Access Program for specific hospitalized COVID-19 patients (“LenzMAPTM”).
Clinigen, a multinational pharmaceutical products and services company, is performing the initiative. Lenzilumab is a research medicine that is not yet approved or authorized in any jurisdiction.
Clinigen is a specialist in offering specialized therapy on just “named-patient-basis” throughout Europe and the United Kingdom.
Lenzilumab is accessible through LenzMAP in seventeen countries: United Kingdom, Croatia, Bulgaria, Cyprus, Austria, Ireland, Denmark, Estonia, Portugal, Greece, Lithuania, Spain, Luxembourg, Netherlands, Sweden, Estonia, and Switzerland.
LenzMAP will provide access to lenzilumab on a patient-to-patient basis for hospitalized COVID-19 patients whose treating physician believes there are no viable alternatives and where regulations allow.
“We are delighted to be partnering with Clinigen to give patient-by-patient access to lenzilumab in the UK and several other European nations,” stated Timothy E. Morris, CFO and COO of Humanigen. “While we pursue our lenzilumab development program and seek appropriate approvals or authorizations for its potential commercial use in the US, United Kingdom, and European Union, LenzMAP will allow Humanigen to accept requests from healthcare providers for access to lenzilumab to treat specific hospitalized patients where permitted by local regulations.”
Clinigen will oversee critical aspects of LenzMAP, including access management, logistics reimbursement, and regulatory monitoring.
“We are delighted to be working with Humanigen to provide this perspective therapy option for some hospitalized COVID-19 patients in the United Kingdom and Europe.” Clinigen’s strength in partnering with biotechnology firms to include services that allow faster and broader access to vital medications is highlighted by LenzMAP,” said Pete Belden, Executive Vice President, Services Division, Clinigen.
Clinigen presently manages over 161 similar controlled access agreements for other firms and has accessibility to over 20,000 health practitioners in 5,000 hospitals in over 120 countries.
“As we transition from the pandemic to the endemic stage of COVID-19, healthcare practitioners continue to witness both vaccinated and unvaccinated individuals with high inflammatory markers,” said Andrea Aroldi, MD, San Gerardo Hospital (Monza, Italy). “With the availability of lenzilumab on a compassionate-use/named-patient basis in certain European countries, clinicians now have another therapy option, an immunomodulator, in their armory of medicines in the fight against COVID-19.”