Abbott submits an sBLA for its tumor necrosis factor inhibitor Humira (adalimumab) for treatment of moderate to severe chronic plaque psoriasis, the company announced April 2. The submission is based on the results of two double-blind, placebo-controlled trials of Humira - REVEAL and CHAMPION - evaluating the biologic based on the Psoriasis Area and Severity Score. The 52-week REVEAL study evaluated more than 1,200 patients with moderate to severe chronic plaque psoriasis, for which 71 percent achieved PASI 75 or better compared to 6.5 percent on placebo. The 16-week CHAMPION study evaluated 271 patients; 80 percent of patients treated with Humira achieved PASI 75 or better compared to 36 percent treated with methotrexate. Humira gained a Crohn's indication Feb. 27, making it the first self-administered biologic approved for Crohn's (1Pharmaceutical Approvals Monthly March 2007, In Brief). The biologic is also approved for rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis...
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
The EU product information for Novo Nordisk’s semaglutide medicines is to be updated to include non-arteritic anterior ischemic optic neuropathy as a side effect with a frequency of “very rare.”
The Pink Sheet explores how regulatory approvals for Leqembi differ around the world, and looks at what is coming next.
Experts from EUCOPE explain why the Council of the EU’s position on the proposed overhaul of the general pharmaceutical legislation could offer more predictability for companies than the commission’s initial offering.
