FDA Grants Fast Track Designation To CERC-002 For Treatment Of Hospitalized COVID-19 Patients

Biopharmaceutical company Cerecor Inc. (CERC) announced Tuesday that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to CERC-002 for treatment of hospitalized patients with COVID-19.

CERC-002 is a first-in-class fully human monoclonal antibody targeting LIGHT (tumor necrosis factor superfamily member 14, TNFSF14) licensed from Kyowa Kirin Co., Ltd.

It is the only clinical stage anti-LIGHT therapy and has the potential to treat a number of LIGHT-associated immune diseases including cytokine storm-induced COVID-19 ARDS.

Fast Track designation is granted to drugs being developed for the treatment of serious or life-threatening diseases or conditions where there is an unmet medical need. Under Fast Track designation, a Biologic License Application (BLA) for CERC-002 is eligible for both rolling submission and priority review.

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