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FDA approves skyrizi for moderately to severely active crohn disease

Skyrizi (risankizumab-rzaa), an interleukin-23 inhibitor, has received U.S. Food and Drug Administration approval to treat moderately to severely active Crohn disease (CD) in adults, according to AbbVie.

Approved dosing for Skyrizi for the treatment of CD is 600 mg by intravenous infusion over at least one hour at week 0, alprazolam bioavailability week 4, and week 8, followed by 360 mg self-administered by subcutaneous injection with an on-body injector at week 12 and every eight weeks thereafter.

The company reported that in two induction trials and one maintenance clinical trial, Skyrizi demonstrated significant improvements in endoscopic response (defined as a decrease of >50 percent from the baseline Simple Endoscopic Score in Crohn disease [SES-CD] or for patients with isolated ileal disease and SES-CD of 4, at least a 2-point reduction from baseline) compared with placebo. Additionally, Skyrizi was associated with clinical remission (defined as a Crohn Disease Activity Index of less than 150) versus placebo, as both an induction and maintenance therapy. Clinical response and clinical remission were seen as early as week 4 in induction studies.

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