StemCell Therapy

The European Medicines Agencys (EMA) Committee for Medicinal Products for Human Use (CHMP) agreed on a positive opinion for AbbVies upadacitinib (RINVOQ), according to the company. The JAK inhibitor is a once-daily selective treatment used for adult patients with moderate to severe active rheumatoid arthritis who are intolerant to 1 or more disease-modifying antirheumatic drugs.

CHMP's positive opinion is a scientific recommendation for marketing authorization to the European Commission, which authorizes marketing approval in the European Union. This opinion is supported by data from a global phase 3 SELECT rheumatoid arthritis program. 4400 patients with moderate to severe active rheumatoid arthritis were evaluated in 5 different trials, including SELECT-NEXT, SELECT-BEYOND, SELECT-MONOTHERAPY, SELECT-COMPARE, and SELECT-EARLY.

All primary and secondary endpoints were met, including low disease activity based on Disease Activity Score 28 C-Reactive Protein. Improved response was seen with upadacitinib, both as a monotherapy and in combination with conventional synthetic DMARDs compared to placebo.

The SELECT program showed a consistent safety profile across all five studies, with the most frequent adverse reactions being infections.

REFERENCE

AbbVie receives chmp positive opinion for upadacitinib (rinvoq) for the treatment of adults with moderate to severe active rheumatoid arthritis [news release]. North Chicago, Ill.; PR Newswire: October 18, 2019. https://www.prnewswire.com/news-releases/abbvie-receives-chmp-positive-opinion-for-upadacitinib-rinvoq-for-the-treatment-of-adults-with-moderate-to-severe-active-rheumatoid-arthritis-300940994.html. Accessed October 18, 2019.

More:
Positive Opinion of Upadacitinib for Active Rheumatoid Arthritis - Pharmacy Times

This entry was posted on October 18, 2019 at 6:46 pm and is filed under Arthritis. You can follow any responses to this entry through the RSS 2.0 feed. Both comments and pings are currently closed. |