Good news for AbbVie as it secures FDA approval for arthritis treatment

AbbVie won approval in the US for its treatment for moderate to severe arthritis, upadacitnib. The treatment met all its primary and secondary endpoints across its Phase three trial, with the trial evaluating approximately 4,400 patients across all treatment arms in the five studies. According to AbbVie, from the trial results, patients taking upadacitnib achieved clinical remission (when symptoms have lessened to the point that they are mostly absent/gone.) Also good for AbbVie, is that upadacitnib improved outcome in patients with rheumatoid arthritis compared to current blockbuster treatment AbbVie’s own Humira.

This is good news for AbbVie, as Humria has been facing a multitude of biosimilar competition, with rapid losses being experienced in Europe (there was a 17.4% decrease in sales recorded in October 2018.) And with US patent protection ending in 2023, AbbVie needs to have a drug that can offset the losses that will inevitably occur. AbbVie had been banking on its new psoriasis treatment Skyrizi to combat Humira’s decline after it was recently fast-tracked by NICE following European Marketing approval. Following this news, AbbVie’s shares increased by 2%.

The treatment is a JAK inhibitor and this market has recently come under scrutiny with safety concerns surrounding the treatment. As the FDA released new safety data that showed that the drug could increase the risks of blood clots.

The treatment will be available for patients who have had an inadequate response to the current standard rheumatoid arthritis in the US later this month. AbbVie is currently awaiting results from Europe and Japan and if positive results are received upadacitnib could well be on track for reclaiming Humira’s lost ground.

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