InflaRx Announces Initiation of its Commitment Program for GOHIBIC(vilobelimab) to Help Broaden Access for Eligible Patients - Seite 2

He added: “Many hospitals struggle to provide patient access to all available medicines, even those that may be lifesaving. So, it is reassuring that InflaRx is willing to reimburse the cost of their medicine in cases where the patient does not survive. This shows me that InflaRx is confident in their product, is doing everything it can to support hospitals and get GOHIBIC to patients who are in critical need of intervention.”

Prof. Niels C. Riedemann, Chief Executive Officer, and Founder of InflaRx, commented: “COVID-19 continues to take far too many lives. Despite this unacceptable situation, patients do not always have access to approved or authorized treatment options. With today´s announcement, we are demonstrating our strong commitment to help make GOHIBIC available for the most affected COVID-19 patients as a potential life-saving therapy. There are currently no approved or authorized alternatives to GOHIBIC, and we believe that all eligible patients and the physicians responsible for their care should have access to this treatment.”

The data supporting the EUA for GOHIBIC was based on a multicenter Phase III (PANAMO) trial, one of the largest 1:1 randomized, double-blind placebo-controlled trials in invasively mechanically ventilated COVID-19 patients in intensive care units. The results showed that treatment with GOHIBIC improved survival, with a relative reduction in 28-day all-cause mortality of 23.9% compared to placebo in the global data set. The data has been published in The Lancet Respiratory Medicine. GOHIBIC is the only drug directed against the complement factor C5a that is authorized for the treatment of certain critically ill COVID-19 patients.

Information for Healthcare Facilities for Ordering GOHIBIC (vilobelimab)
Healthcare facilities can order GOHIBIC from ASD Healthcare (i) by calling 1-800-746-6273 or (ii) by e-mailing [e-mail]. Please provide the product and notational drug code (NDC): GOHIBIC (NDC 83000-0110-04).

For detailed information about the Commitment Program and to file a claim, please visit this link: The InflaRx Commitment Program.

About the EUA for GOHIBIC (vilobelimab)
The FDA has issued an EUA for the emergency use of GOHIBIC for the treatment of COVID-19 in hospitalized adults when initiated within 48 hours of receiving IMV or ECMO.

GOHIBIC has not been approved but has been authorized for emergency use by FDA under an EUA for the treatment of COVID-19 in hospitalized adults when initiated within 48 hours of receiving IMV or ECMO.