Tuesday , April 24 2018
Home / Psoriasis

Psoriasis

Pfizer’s Xeljanz and Xeljanz XR Receive FDA Approval for the Treatment of Active Psoriatic Arthritis

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) announced today that the United States Food and Drug Administration (FDA) has approved XELJANZ® 5 mg twice daily (BID) and XELJANZ® XR (tofacitinib) extended release 11 mg once daily (QD) for the treatment of adult patients with active psoriatic arthritis (PsA) who have had an inadequate response …

Read More »

FDA Approves Pfizer’s Ixifi, a Biosimilar to Remicade

Pfizer Inc. (NYSE:PFE) announced today that the United States (U.S.) Food and Drug Administration (FDA) has approved IXIFI™ (PF-06438179, infliximab-qbtx), a chimeric human-murine monoclonal antibody (mAb) against tumor necrosis factor, as a biosimilar to Remicade® (infliximab)* for all eligible indications of the reference product.1 The FDA has approved IXIFI as …

Read More »

Lilly’s Taltz Receives FDA Approval for the Treatment of Active Psoriatic Arthritis

INDIANAPOLIS, Dec. 1, 2017 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has approved Taltz® (ixekizumab) injection 80 mg/mL for the treatment of adults with active psoriatic arthritis (PsA).1 Taltz was first approved by the FDA in March 2016 for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for …

Read More »

FDA Accepts Ortho Dermatologics’ NDA for IDP-118 for the Treatment of Plaque Psoriasis

LAVAL, Quebec, Nov. 2, 2017 /PRNewswire/ — Ortho Dermatologics, a division of Valeant Pharmaceuticals International, Inc. (NYSE: VRX and TSX: VRX), today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for IDP-118 (halobetasol propionate and tazarotene) lotion, an investigational topical treatment for …

Read More »

AbbVie’s Risankizumab Beats Humira and Stelara in Late-Stage Psoriasis Studies

NORTH CHICAGO, Ill., Oct. 26, 2017 /PRNewswire/ — AbbVie (NYSE: ABBV), a global research and development-based biopharmaceutical company, today announced positive top-line results from three pivotal Phase 3 clinical trials evaluating risankizumab, an investigational interleukin-23 (IL-23) inhibitor, compared to ustekinumab and adalimumab for the treatment of patients with moderate to severe chronic plaque …

Read More »

Janssen’s Simponi Aria Receives FDA Approval for Psoriatic Arthritis and Ankylosing Spondylitis

Horsham, Pa., October 20, 2017 ― Janssen Biotech, Inc., announced today that the U.S. Food and Drug Administration (FDA) has approved SIMPONI ARIA® (golimumab), the only fully-human anti-tumor necrosis factor (TNF)-alpha therapy administered via a 30-minute infusion, for the treatment of adults with active psoriatic arthritis (PsA) or active ankylosing spondylitis (AS). Today’s …

Read More »

Prothena Discontinues Development of PRX003 in Psoriasis Following Negative Trial Results

DUBLIN, Ireland, Sept. 28, 2017 (GLOBE NEWSWIRE) — Prothena Corporation plc (Nasdaq:PRTA), a late-stage clinical biotechnology company focused on the discovery, development and commercialization of novel protein immunotherapies, today announced clinical results of a Phase 1b multiple ascending dose (MAD) study of PRX003 in patients with psoriasis. PRX003 is a …

Read More »

Novartis’ Cosentyx Sets New Benchmark in Psoriasis with Robust 5-Year Sustained Phase 3 Efficacy and Safety Data

Basel, September 13, 2017 – Novartis announced today, first of its kind Phase III data showing Cosentyx® (secukinumab) delivered high and long-lasting skin clearance in patients with moderate-to-severe plaque psoriasis at 5 years[1]. These data were presented for the first time at the 26th European Academy of Dermatology and Venereology (EADV) Congress in Geneva, …

Read More »

Janssen’s Tremfya Receives FDA Approval for Treatment of Plaque Psoriasis

HORSHAM, Pa., July 13, 2017 /PRNewswire/ — Janssen Biotech, Inc. (Janssen) announced today that the U.S. Food and Drug Administration (FDA) has approved TREMFYA™ (guselkumab) for the treatment of adults living with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. TREMFYA™ is the first and …

Read More »

FDA Approves Bristol-Myers Squibb’s Orencia for Treatment of Active Psoriatic Arthritis

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE:BMY) announced today the U.S. Food and Drug Administration (FDA) has approved ORENCIA for the treatment of adults with active Psoriatic Arthritis (PsA)1, a chronic2, inflammatory disease that can affect both the skin and musculoskeletal system.3 ORENCIA is approved and available in both intravenous and subcutaneous (SC) …

Read More »