The Food and Drug Administration has approved a new drug for rheumatoid arthritis made by AbbVie.
The Chicago-based drugmaker said Friday that the FDA had approved Rinvoq (upadacitinib) for patients with moderately to severely active RA who had not responded adequately to the drug methotrexate. The drug, which the company expects to make available later this month, is a JAK inhibitor meant to be administered once daily.
Shares of AbbVie were up 2.8 percent Monday morning on the New York Stock Exchange following the news. Reuters reported that the drug would carry a list price of $59,000 per year.
AbbVie’s top-selling drug is Humira (adalimumab), which is also approved for RA and other autoimmune conditions, with sales of $3.8 billion in the second quarter of this year. But the drug has lost patent protection, and there are now four biosimilars with FDA approval. The most recent was Bioepis’ Hadlima (adalimumab-bwwd), which the agency approved in July.
The approval of Rinvoq is based on the Phase III SELECT trial program, comprising five studies: SELECT-EARLY, SELECT-MONOTHERAPY, SELECT-COMPARE, SELECT-NEXT and SELECT-BEYOND. The trials tested the drug in various settings of RA, including methotrexate-intolerant – the basis of the label granted by the FDA – as well as methotrexate-naive and patients intolerant to disease-modifying antirheumatic drugs (DMARDs) and biologics, both classes that include Humira.
“Despite the availability of multiple treatment options with varying mechanisms of action, many patients still do not achieve clinical remission or low disease activity, the primary treatment goals for rheumatoid arthritis,” said SELECT-COMPARE primary investigator Dr. Roy Fleischmann of the University of Texas Southwestern Medical Center in Dallas, in a statement. “With this FDA approval, Rinvoq has the potential to help additional people living with RA achieve remission who have not yet reached this goal.”
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
One of those multiple treatment options may eventually include another JAK inhibitor, Gilead Sciences and Galapagos’ filgotinib. The companies said Thursday that the European Medicines Agency had validated their approval application for the drug as a once-daily oral treatment for RA, and the companies plan to file for FDA approval this year as well. That drug’s Phase III program includes patients with inadequate responses to methotrexate and DMARDs as well as patients who are methotrexate-naive.
Photo: AbbVie
