The Galien Foundation has revealed its latest nominees for the 2021 Prix Galien USA Award highlighting innovations in biotechnology, pharmaceutical agents, medical technology and digital health products. Entrants to the competition must have received FDA approval within the past five years and demonstrate exceptional therapeutic potential. The Galien Foundation does not use financial data to…
Olumiant offers hope to patients with rheumatoid arthritis
FDA has indicated Lilly‘s OLUMIANT (baricitinib) to treat adult patients with moderately to severely active rheumatoid arthritis. In particular, the agency has recommended the drug for patients with an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies. In June, Lilly and its partner Incyte announced that the drug appeared to reduce…
Rinvoq could hold promise for atopic dermatitis
The Janus kinase (JAK) inhibitor Rinvoq (upadacitinib) from AbbVie and Incyte has a current indication for moderate to severe active rheumatoid arthritis for patients with an inadequate response or intolerance to the immunosuppressant methotrexate. Rinvoq is seeking expanded approval for the drug to treat moderate to severe atopic dermatitis (AD), which is a form of…
Why Janssen believes next-gen drug Tremfya can meet unmet needs in psoriasis and beyond
Two decades ago, psoriasis was a poorly understood condition. Treatment options for severe psoriasis included powerful immunosuppressant agents such as methotrexate and cyclosporin that can have significant side effects. But the fact those immunosuppressant drugs were effective at treating psoriasis helped pave the way to use biologics to treat the condition. The experience “really taught…
How lupus clinical trials are evolving
In the past half-century, scores of investigational drugs for lupus have seemingly failed in clinical trials. GSK’s Benlysta (belimumab) is unique in winning approval from the FDA and European regulatory authorities. Anifrolumab from AstraZeneca, which would be a first-in-class type I interferon inhibitor, is one of the most promising investigational drugs for treating systemic lupus…
AstraZeneca’s TULIP trials highlight role of interferon in lupus
A recent post hoc analysis from AstraZeneca (LON:AZN) found that the monoclonal antibody anifrolumab (Saphnelo) led to consistent improvements in skin rash and arthritis in patients with systemic lupus erythematosus (SLE), which is the most common lupus type. A pooled analysis of the Phase 3 TULIP-1 and TULIP-2 clinical trials investigating anifrolumab showed the drug led…
Anifrolumab data promising for systemic lupus erythematosus
AstraZeneca (LON:AZN) has announced that a new posthoc analysis of data from the TULIP Phase 3 clinical trials of anifrolumab showed promise in patients with systemic lupus erythematosus (SLE), the most common type of lupus. Anifrolumab is a monoclonal antibody that blocks the activity of interferons such as interferon-α and interferon-β. If approved, anifrolumab would be…
Lilly’s Taltz leads to durable improvement in axial spondyloarthritis in Phase 3 study
Eli Lilly and Company (NYSE:LLY) has announced that recent Phase 3 data suggest Taltz (ixekizumab) was effective in the long-term management of axial spondyloarthritis (axSpA). Taltz, an interleukin-17A antagonist, is currently indicated for plaque psoriasis, psoriatic arthritis and active ankylosing spondylitis. In the COAST-Y study, Taltz demonstrated long-term improvements in patients’ symptoms with the two subtypes of…
J&J’s Tremfya shows promise in psoriatic arthritis patients who are TNFi non-responders
The Janssen division of Johnson & Johnson (NYSE:JNJ) has announced that its selective IL-23 inhibitor Tremfya (guselkumab) led to joint symptom improvement and skin clearance in the majority of patients with an inadequate response to tumor necrosis factor inhibitors (TNFi’s). After 24 weeks of treatment, 44.4% of patients who received Tremfya had at least a…