Humanigen, a Californian clinical-stage biopharma company focused on preventing and treating an immune hyper-response called ‘cytokine storm’, has entered into an arrangement with Clinigen to implement a Managed Access Program for lenzilumab (LenzMAP).
LenzMAP will enable access to lenzilumab on a case-by-case basis for hospitalised patients with COVID-19 where the treating physician deems there to be no suitable alternatives and where regulations allow.
To date there have been over 20 million cases of COVID-19 reported in these countries.1 Lenzilumab is an investigational product and is not currently authorized or approved in any country.
“We are working with Clinigen to provide access to lenzilumab on a patient-by-patient basis in specific European countries,” said Timothy E. Morris, COO and CFO of Humanigen.
“While we continue to pursue a Marketing Authorization Application for lenzilumab and await the associated review by the European Medicines Agency, as well as a decision regarding conditional marketing authorization, the Managed Access Program will enable Humanigen to respond positively to requests for access from healthcare professionals to treat hospitalized patients where allowed by the local regulatory authorities.”
Under the terms of the agreement, Clinigen will manage key elements of the program including regulatory oversight, logistics and access management.
Humanigen will rely on Clinigen’s expertise working with regulatory authorities in the relevant countries to make access to lenzilumab possible in each of the 16 nations identified above.
Clinigen currently oversees more than 161 similar managed access programs for other companies. Clinigen has access to over 20,000 healthcare providers in 5,000 hospitals across more than 120 countries.
LenzMAP will be available in the following 16 European countries: Austria, Bulgaria, Croatia, Cyprus, Denmark, Estonia, France, Greece, Ireland, Lithuania, Luxembourg, Netherlands, Portugal, Spain, Sweden, and Switzerland.