Denosumab’s labeling now says a patient’s risk of developing osteonecrosis of the jaw may increase with prolonged exposure…
FDA Update: Committees Recommend Approvals for Abuse-Deterrent Opioid & Brodalumab
FDA advisory committees recommend the approvals of the abuse-deterrent opioid morphine sulfate for pain and brodalumab for plaque psoriasis…
Rheumatology Drug Updates: Infliximab Biosimilar Cross Reacts to Infliximab Antibodies
Cross Reactions A recent study published online in March in the Annals of the Rheumatic Diseases investigated if the infliximab biosimilar (CT-P13, infliximab-dyyb), which is marketed in Europe as Inflectra and Remsima, can be safely and effectively substituted for infliximab (Remicade).1 Infliximab and its biosimilar are manufactured via the same process. Researchers set out to…
Ixekizumab Improves Work Productivity in Patients with Plaque Psoriasis
In three clinical trials, ixekizumab proved more effective than placebo or etanercept at increasing the work attendance and productivity of patients with plaque psoriasis…
Humira Found Partially Effective against Hidradenitis Suppurativa
NEW YORK (Reuters Health) – The anti-inflammatory drug adalimumab can provide significant relief for about a quarter of people who suffer from a moderate-to-severe case of the chronic skin condition hidradenitis suppurativa, according to two 36-week trials. But the drug – which would cost over $104,000 per year for the weekly injections used in the…
Generic TNF-Alpha Inhibitors Comparable to Established Brands
NEW YORK (Reuters Health)—Biosimilar tumor necrosis factor-alpha inhibitors appear equivalent to the branded original versions, according to a systematic review and meta-analysis. As Dr. G. Caleb Alexander tells Reuters Health by email, “biologic treatments represent a rapidly growing proportion of prescription drug expenditures and thus there is enormous interest in whether or not biosimilar products…
New RA Therapy Promising in Clinical Trial
Results from a clinical trial support the efficacy of vobarilizumab for treating RA. Plus, the UK will recommend the use of certolizumab pegol to treat severe cases of RA in upcoming guidelines…
Secukinumab Inhibits Structural Joint Damage in Active PsA
Psoriatic arthritis (PsA), a chronic inflammatory arthritis characterized by structural damage to the joints, has been associated with reduced health-related quality of life, disability and reduced life expectancy. The joint changes in PsA are characterized radiographically by a combination of erosive and proliferative bone changes, including erosive joint destruction, fluffy periostitis and pencil-in-cup deformities. Radiographic…
U.S. FDA Panel Backs Valeant Psoriasis Drug with Risk Program
(Reuters)—Valeant Pharmaceuticals International Inc.’s experimental drug to treat psoriasis should be approved as long as certain measures are put in place to mitigate the risk of suicide, an advisory committee to the U.S. Food and Drug Administration concluded on Tuesday. The FDA is not obliged to follow the advice of its advisory committees but typically…
Tildrakizumab Promising for Plaque Psoriasis; FDA Approves Adalimumab to Treat Panuveitis
n clinical trials, tildrakizumab was more effective than etanercept and placebo at treating moderate to severe plaque psoriasis. Adalimumab has received approval for treating non-infectious intermediate, posterior and panuveitis—its 10th FDA indication…
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