Janssen Research & Development, LLC (Janssen) presented new longer-term data from the open-label extension of the VOYAGE1 trial demonstrating consistent rates of skin clearance with TREMFYA™ treatment through week 100 among patients with moderate to severe plaque psoriasis receiving the subcutaneously administered anti-interleukin (IL)-23 monoclonal antibody. The longer-term findings from the Phase 3 VOYAGE 1 study presented at the 26th European Academy of Dermatology and Venereology (EADV) Congress showed more than 80 percent of patients receiving TREMFYA™, including those initially treated with placebo or the anti-tumor necrosis factor (TNF)-alpha agent Humira® (adalimumab) achieved at least a 90 percent improvement in the Psoriasis Area Severity Index (PASI 90), or near complete skin clearance, and an Investigator’s Global Assessment (IGA) score of clearedor minimal disease at week 100. The findings, presented during an EADV late-breaker session, follow the recent European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommendation for approval of TREMFYA™, and the United States Food and Drug Administration (FDA) approval of TREMFYA™ in July.
Merck KGaA, Darmstadt, Germany, and Pfizer Inc. announced that the European Commission (EC) has granted marketing authorization for BAVENCIO® (avelumab) as a monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma (mMCC), a rare and aggressive skin cancer. BAVENCIO will have marketing authorization in the 28 countries of the European Union (EU) in addition to Norway, Liechtenstein and Iceland. BAVENCIO is expected to become commercially available to patients in Europe by prescription within the coming months, with initial launches in Germany and UK expected as early as October 2017.
Pfizer filed suit in the U.S. District Court for the Eastern District of Pennsylvania against Johnson & Johnson (J&J).
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