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The US Food and Drug Administration (FDA) has approved the expanded use of Johnson & Johnson\u2019s drug \u200bImaavy to treat a rare blood disorder, the company said on Monday.<\/strong><\/p>\n The \u200capproval makes Imaavy the first treatment cleared for warm autoimmune hemolytic anemia, or wAIHA, and covers patients aged 12 and older who are currently or were previously treated with steroids.<\/p>\n Imaavy blocks \u2060a protein that keeps harmful antibodies in the bloodstream, lowering their levels \u200bwhile preserving other immune functions. The drug is infused into a vein every \u200bfour weeks at a dose based on weight.<\/p>\n \u201cImaavy was able to demonstrate patients can go down on their steroids and still maintain that clinical response. Those are really important advances for \u200bpatients,\u201d Johnson & Johnson\u2019s global immunology head David Lee told Reuters.<\/strong><\/p>\n<\/blockquote>\n The approval was \u200bbased on a mid-to-late-stage study of 115 adults in which about three times as many patients \u200creceiving \u2060Imaavy achieved a lasting improvement in hemoglobin levels after 24 weeks as those on placebo.<\/p>\n Hemoglobin carries oxygen in red blood cells.<\/p>\n The most common side effects were swelling in the arms or legs, diarrhea and fever. Imaavy can also \u200braise the risk \u200bof infections and \u2060cause serious allergic or infusion-related reactions, according to its prescribing information.<\/p>\n Lee said existing treatments also have toxicities and may not \u200badequately control the disease. He said Imaavy improved and stabilized \u200bpatients\u2019 blood \u2060counts in the study.<\/p>\n About one in 8,000 people have wAIHA, with one to three new cases diagnosed annually per 100,000 people, according to Johnson & Johnson.<\/p>\n Imaavy was first \u2060approved in \u200bApril last year to treat generalized myasthenia gravis \u200bin certain adults and patients aged 12 and older. The rare immune disorder causes muscle weakness.<\/p>\n<\/div>\n\n