Is Upadacitinib approved by the FDA?

Yes, upadacitinib is FDA approved. Upadacitinib, marketed under the brand names Rinvoq and Rinvoq LQ, is an oral Janus kinase (JAK) inhibitor used to treat a variety of inflammatory conditions. The FDA first approved upadacitinib on August 16, 2019, for the treatment of moderate to severe rheumatoid arthritis in adults who have not responded well to methotrexate or other similar medications . Subsequently, Rinvoq LQ, a liquid formulation of upadacitinib, received FDA approval on April 26, 2024 .

What is Upadacitinib?

Upadacitinib works by inhibiting the activity of the Janus kinase enzymes, which play a crucial role in the inflammatory process. This inhibition helps reduce the immune system's activity, thus alleviating symptoms of several inflammatory conditions. It can be used alone or in combination with other medications to manage various autoimmune diseases, including:

• Rheumatoid arthritis: For patients who cannot take or have not responded well to TNF inhibitors.
• Psoriatic arthritis: For adults who did not respond to or tolerate TNF inhibitors.
• Atopic dermatitis: For adults and children aged 12 and older who cannot use or have not responded to other medications.
• Ulcerative colitis: For adults who have not responded to TNF inhibitors.
• Crohn's disease: For adults who did not respond to TNF inhibitors.
• Ankylosing spondylitis: For adults who did not respond to TNF inhibitors.
• Non-radiographic axial spondyloarthritis: For adults who did not respond to TNF inhibitors.
• Polyarticular juvenile idiopathic arthritis: For children aged 2 years and older who have had an inadequate response or intolerance to TNF blockers .

Formulations and Dosage

Upadacitinib is available in two formulations: Rinvoq extended-release tablets and Rinvoq LQ liquid solution. These formulations are not interchangeable and are prescribed based on the specific needs of the patient and their condition .

Side Effects and Warnings

While upadacitinib can be highly effective, it also carries the risk of serious side effects. These can include infections, heart attacks, strokes, and certain cancers. Patients should be monitored regularly, and any unusual symptoms should be reported to a healthcare provider immediately. Common side effects include flu-like symptoms, nausea, rash, headache, stomach pain, and weight gain .

Conclusion

Upadacitinib, approved by the FDA in 2019 under the brand name Rinvoq and later in 2024 as Rinvoq LQ, is a significant treatment option for various inflammatory and autoimmune diseases. Its efficacy and safety profile, while generally favorable, require careful consideration and monitoring due to the potential for serious side effects. Always consult with a healthcare professional before starting or modifying treatment with upadacitinib.

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