The Food and Drug Administration (FDA) has granted Orphan Drug designation to dexpramipexole (Knopp Biosciences), an investigational treatment for hypereosinophilic syndrome (HES). HES is characterized by peripheral eosinophilia with evidence of organ involvement. Treatment depends on the severity of the condition and underlying cause; while steroid therapy is effective in most patients, high doses are…
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The Food and Drug Administration (FDA) has granted Fast Track designation to the investigational oral dual inhibitor, ASN002 (Asana BioSciences), for the treatment of moderate-to-severe atopic dermatitis.
The FDA decision to grant Priority Review was based on results from a National Institute of Health (NIH) study which demonstrated a 52% complete response rate and an 85% overall response rate in treatment-naïve SAA patients treated with eltrombopag plus standard IST.
The disease can be life threatening. Phase 3 study results released last March demonstrated Rituxan substantialy improved pemphigus vulgaris remission rates and successful tapering.
The primary endpoint was met with 75% of the benralizumab group reducing their OCS doses compared to 25% in the placebo group. Additionally, 52% of the benralizumab group who had optimized baseline OCS doses of ≤12.5mg/d were able to completely stop OCS use.