The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has recommended the plaque psoriasis drug guselkumab (Tremfya, Janssen-Cilag International NV) for approval.
The CHMP supported the use of guselkumab for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy, according to an EMA news release.
“We are pleased guselkumab may soon be available to adults living with moderate to severe plaque psoriasis in Europe, because the evidence shows this novel therapeutic offers significant and lasting efficacy for patients in need of alternative treatment options,” said José Antonio Burόn Vidal, Janssen vice president of medical affairs, Europe, Middle East, and Africa, in a statement.
The company said that 14 million people in Europe have plaque psoriasis.
The European panel based its recommendation on data from the VOYAGE 1 and 2 trials, which showed that guselkumab was superior to adalimumab (Humira, AbbVie Inc), and on additional data from the NAVIGATE study, in which patients were switched from ustekinumab (Stelara, Janssen) to guselkumab.
Janssen said that it expects a final approval decision from the European Commission later in 2017. The self-injectable therapy ― the first to selectively target IL-23, a key driver of the immune inflammatory response in patients with psoriasis ― requires two starter doses, followed by one dose once every 8 weeks.
Guselkumab is already on the market in the United States. It was approved by the US Food and Drug Administration in July for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
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