Janssen Biotech has filed a Biologics License Application (BLA) with the US Food and Drug Administration approval of its investigational anti-interleukin-23 monoclonal antibody.
Janssen, a subsidiary of US healthcare giant Johnson & Johnson (NYSE: JNJ), is seeking marketing approval for guselkumab for the treatment of adults living with moderate to severe plaque psoriasis.
Psoriasis is a chronic, autoimmune inflammatory disorder that results in the overproduction of skin cells, characterized by raised, inflamed, scaly, red lesions, or plaques, which can cause itching, discomfort and pain. It is estimated that 7.5 million Americans have psoriasis, which can range from mild to severe and disabling.
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