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AbbVie submits applications for Upadacitinib in to US FDA and EMA ExpressPharma
January 10, 2022
In the trial study, evaluating the efficacy and safety of Upadacitinib in adult patients with nr-axSpA, Upadacitinib met its primary and most-ranked secondary endpoints.
AbbVie seeks approval for upadacitinib to treat nr-axSpA pharmaceutical-business-review
January 10, 2022
Abbvie has submitted applications to the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to obtain approvals...
Rinvoq® shows positive results in rheumatoid arthritis post-hoc analysis EuropeanPharmaceuticalReview
November 10, 2021
AbbVie has announced new results from a post-hoc analysis of the Phase III SELECT-BEYOND clinical trial evaluating Rinvoq® (upadacitinib; 15mg, once daily) in patients with moderate...
USFDA extends review period for AbbVie’s sNDA of upadacitinib pharmaceutical-business-review
March 18, 2021
The US Food and Drug Administration (FDA) has extended the review period for AbbVie’s supplemental New Drug Application (sNDA) for upadacitinib.
Upadacitinib meets all endpoints in Phase III ulcerative colitis trial europeanpharmaceuticalreview
February 24, 2021
In the trial, 74 percent of participants responded to upadacitinib and 33 percent of patients achieved clinical remission.
Upadacitinib Meets Primary, All Ranked Secondary Endpoints in Ulcerative Colitis Study americanpharmaceuticalreview
December 10, 2020
AbbVie announced positive results from the Phase 3 induction study, U-ACHIEVE, which showed upadacitinib (45 mg, once daily) met the primary endpoint of clinical remission (per Adapted Mayo Score) at week 8, as well as all ranked secondary endpoints ...
New Long-Term Data from Upadacitinib Phase 3 Studies in Rheumatoid Arthritis Including Results on Clinical Remission at 48 Weeks Presented at EULAR drugs
June 19, 2019
New Long-Term Data from Upadacitinib Phase 3 Studies in Rheumatoid Arthritis Including Results on Clinical Remission at 48 Weeks Presented at EULAR.
AbbVie’s JAK inhibitor upadacitinib gets Priority Review pharmaphorum
February 21, 2019
AbbVie’s attempts to diversify beyond Humira have been boosted as its investigational drug upadacitinib has been granted Priority Review by the FDA for moderate to severe rheumatoid arthritis (RA).
FDA agrees to review AbbVie’s upadacitinib in rheumatoid arthritis pharmaceutical-technology
February 21, 2019
The US Food and Drug Administration (FDA) has accepted a new drug application (NDA) submitted by AbbVie for its investigational medicine upadacitinib to treat adults with moderate to severe rheumatoid arthritis....
AbbVie seeks US and European authorisations for upadacitinib pharmaceutical-technology
December 24, 2018
AbbVie has submitted applications to the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), seeking approvals for .....

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