Clinigen Group has set up an exclusive managed access program in Europe for Humanigen's anti-inflammatory drug lenzilumab.
Humanigen is developing lenzilumab as a treatment for cytokine storm associated with Coronavirus (COVID-19) and CD19-targeted CAR-T cell therapies and in other inflammatory conditions including rheumatoid arthritis.
Lenzilumab is an investigational product and is not currently authorized or approved in any country but through the program patients can be prescribed the drug by their doctor.
The managed access programme will be available in 16 European countries: Austria, Bulgaria, Croatia, Cyprus, Denmark, Estonia, France, Greece, Ireland, Lithuania, Luxembourg, Netherlands, Portugal, Spain, Sweden, and Switzerland.
Pete Belden (NYSE:BDC), Clinigen’s executive vice president Services Division, said: "We are pleased to partner with Humanigen to offer this important treatment option to help address a significant unmet need for hospitalised patients across Europe.
Timothy E Morris Humanigen’s chief operating officer said: "While we complete 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 competent authorities.“