Following swiftly on a US regulatory filing, US healthcare giant Johnson & Johnson (NYSE: JNJ) has now applying to get clearance for its blockbuster-potential plaque psoriasis drug.
Subsidiary Janssen-Cilag International said today that it had submitted a Marketing Authorization Application to the European Medicines Agency seeking approval of guselkumab for the treatment of adults living with moderate to severe plaque psoriasis.
Guselkumab is a human monoclonal antibody that targets the protein interleukin (IL)-23, which has been shown to play a key role in the development of immune-mediated inflammatory diseases. Psoriasis is a chronic, autoimmune inflammatory disorder that results in the overproduction of skin cells, characterised by raised, inflamed, scaly, red lesions, or plaques, which can cause itching, discomfort and pain. It is estimated that 14 million Europeans have psoriasis, which can range from mild to severe and disabling, and can often significantly impair quality of life.
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