AbbVie Report Results of Rinvoq (upadacitinib) in Second P-III Induction Study for Ulcerative Colitis

Shots:

  • The P-III U-ACCOMPLISH induction study involves assessing upadacitinib (45 mg, qd) vs PBO in patients with mod. to sev. UC
  • The study met its 1EPs @8wks. i.e, patients achieved clinical remission (per Adapted Mayo Score) (31% vs 4%); met its 2EPs i.e clinical response @8wks. & @2wks. (74% vs 25% & 63% vs 26%); endoscopic improvement (44% vs 8%); histologic endoscopic mucosal improvement (37% vs 6%)
  • The safety results were consistent with the previous P-III induction study, with no new safety risks observed. Rinvoq is a selective and reversible JAK inhibitor, being studied as an oral therapy for mod. to sev. UC and several other immune-mediated diseases

Click here ­to­ read full press release/ article | Ref: Abbvie | Image: Top Employers Institute

The post AbbVie Report Results of Rinvoq (upadacitinib) in Second P-III Induction Study for Ulcerative Colitis first appeared on PharmaShots.

Bausch Health Initiates Second P-III Study for NOV03 (perfluorohexyloctane) to Treat DED Associated With MGD

Shots:

  • The enrollment of the first P-III study is currently underway & has reached 85% of its enrollment goal. In a P-II study of 336 patients, NOV03 met its 1EP of efficacy i.e. improvement of total corneal fluorescein staining over control @8wks.
  • Additionally, NOV03 showed improvement of certain symptoms, such as severity & frequency of dryness & burning/stinging of the eyes, over the entire duration of the P-II study with no notable safety events
  • NOV03 is an investigational, water-free & preservative-free solution, based on patented EyeSol technology from Novaliq

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: SPJNews

The post Bausch Health Initiates Second P-III Study for NOV03 (perfluorohexyloctane) to Treat DED Associated With MGD first appeared on PharmaShots.