AbbVie has won Food and Drug Administration (FDA) approval in the US for upadacitinib in the treatment of moderate to severe rheumatoid arthritis.
The oral JAK inhibitor met all primary and secondary endpoints across its phase 3 SELECT programme, which supported the FDA’s decision to approve the drug. The programme evaluated approximately 4,400 patients across all treatment arms in five studies.
It will be made available in the US in late August 2019, for patients within this therapy area who have had an inadequate response or intolerance to methotrexate, the standard treatment for rheumatoid arthritis (RA).
According to AbbVie, patients taking upadacitinib achieved clinical remission, with almost no disease activity and symptoms. The trial also showed that upadacitinib improved outcomes in RA patients compared to Humira, AbbVie’s blockbuster anti-TNF drug which is approved in the same indication.
Humira has been hit hard by the recent launch of biosimilars, with the drug experiencing rapid losses in Europe. AbbVie has been betting on its new products upadacitinib for RA and Skyrizi for psoriasis to combat Humira’s decline. The Boehringer Ingelheim-partnered psoriasis treatment received a fast-track recommendation from NICE following European marketing approval earlier this year.
Following the news, AbbVie shares were up 2%, a positive outcome for the American pharma company. Biosimilar competition is already harming Humira in Europe and AbbVie needs its new products to offset the expected competition in the US market from 2023 when its patent expires. However, it will be tough for the products to live up to Humira, which brought in $20bn in 2018.
The JAK inhibitor market competition has also become increasingly saturated and upadacitinib will be taking on Pfizer’s Xeljanz and Eli Lilly’s Olumiant when it comes to market. However, there have been some safety concerns regarding the class, with the FDA releasing new safety data on Xeljanz earlier this year which showed that the drug could increase the risks of blood clots.
Upadacitinib faces the same concerns, with AbbVie adding blood clot risks to the treatments label. However, the pharma company does not see these side effects posing a risk to sales of the drug, with suggestions that the risks are manageable.
Following this approval by the FDA, AbbVie is hoping to continue upadacitinib’s upward trajectory, with the drug currently under review by the European Medicines Agency and regulatory authorities in Canada and Japan. If approved in Europe, AbbVie could begin to reclaim Humira’s lost ground in RA.