Healthcare company The Janssen Pharmaceutical Companies of Johnson & Johnson revealed on Wednesday the receipt of approval from the US Food and Drug Administration (FDA) for TREMFYA (guselkumab) for treating adults with moderate-to-severe plaque psoriasis in the nation.

Psoriasis is a chronic, autoimmune inflammatory disorder that results in the overproduction of skin cells, characterized by raised, inflamed, red lesions, or plaques, which can cause physical pain and itching.

TREMFYA is a human monoclonal antibody that selectively blocks the protein interleukin (IL)-23 and is approved for the treatment of adult patients with moderate-to-severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet or UV light), added the company.

According to the company, TREMFYA (guselkumab) is the first US FDA-approved medication of its kind to offer the One-Press patient-controlled injector. One-Press was designed to fit comfortably in the hand and offers a controlled injection that hides the needle throughout the process. It is administered as a 100 mg subcutaneous injection once every eight weeks, after starter doses at weeks zero and four, under the guidance and supervision of a physician.

Under the company's Phase 3, multicentre and randomized ORION study, the patient experience with One-Press was assessed through a validated Self-Injection Assessment Questionnaire (SIAQ), which evaluated patient experience at weeks zero, four and 12 on a scale of zero (worst) to ten (best) across six domains. The mean score for "Satisfaction with Self Injection" was 9.18 (with ten indicating "Very Satisfied") and the mean score for "Ease of Use" was 9.24 (with ten indicating "Very Easy").