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AbbVie's New Generation JAK inhibitor Looks Good But CV Specter Looms

 
• By Alexandra Shimmings

More Phase III data for AbbVie's selective JAK1 inhibitor upadacitinib appear to back a potential best-in-class claim but eyes remain on safety after a death from pulmonary embolism.

Autumn
Will CV events spook regulators? • Source: Shutterstock

Top-line data from the second of six Phase III studies of AbbVie Inc.'s investigational oral JAK1-selective inhibitor, upadacitinib (ABT-494), SELECT-BEYOND, show that it hit its endpoints in patients with moderate to severe rheumatoid arthritis who had not responded to, or were intolerant of, biological disease-modifying antirheumatic drugs (bDMARDs).

However, reports of two deaths in the study in patients receiving the drug – one from pulmonary embolism – plus a second (non-fatal) PE case have raised

More from Clinical Trials

Leo Roars To A Profit In Q1 As Adbry Grows In US

 
• By Kevin Grogan

The Danish firm's atopic dermatitis drug is holding its own despite strong competition from Sanofi/Regeneron’s Dupixent.

Azafaros Banks Over €130m To Advance Nizubaglustat Into Phase III

 
• By Kevin Grogan

The therapy has been developed for GM1 and GM2 gangliosidoses and Niemann-Pick disease type C.

Lilly Builds Obesity Momentum With New SURMOUNT Data Besting Novo Nordisk

 
• By Alaric DeArment

The presentation and publication of the Phase IIIb study showing greater efficacy for Zepbound over Wegovy come at a time when competition has been heating up between the two obesity medications.

Insilico Fast-Tracks First AI-Designed TNIK Inhibitor For IPF

 
• By Dexter Jie Yan

InSilico will leapfrog Phase IIb to progress its AI-generated candidate for idiopathic pulmonary fibrosis directly into a Phase III trial in China, as it prepares for an IPO in Hong Kong.

More from R&D

Azafaros Banks Over €130m To Advance Nizubaglustat Into Phase III

 
• By Kevin Grogan

The therapy has been developed for GM1 and GM2 gangliosidoses and Niemann-Pick disease type C.

Lilly Builds Obesity Momentum With New SURMOUNT Data Besting Novo Nordisk

 
• By Alaric DeArment

The presentation and publication of the Phase IIIb study showing greater efficacy for Zepbound over Wegovy come at a time when competition has been heating up between the two obesity medications.

Which Firms Are Most Exposed To Prasad’s Possible Accelerated Approvals Clampdown?

 
• By Andrew McConaghie

Vaccine and accelerated approvals are expected to face greater scrutiny under new CBER leader Vinay Prasad, but he has promised “no light switch change” to policy, giving some reassurance to companies whose share prices have been battered.