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

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).

More from Clinical Trials

UK Promises To ‘Turbo-Charge’ Clinical Trials As Tariff Threat Remains

 

Faced with Trump’s hostile tariff moves, the UK aims to speed up clinical trial start times to support its pharma sector and invest £600m in a new health data research service.

PureTech Weighs Up Pros And Cons Of Going Private

 
• By 

The biotech has rejected a takeover bid from Nordic Capital but a sale to private equity could be a solution to the public market's continued reluctance to adequately value PureTech’s hub-and-spoke business model.

Epsilogen Hits Antibody Acquisition Trail With TigaTx Takeover

 
• By 

Following the near-total dominance of IgG antibodies, the UK group is backing the potential of IgA and IgE-based therapies to transform cancer treatment with the purchase of US-headquartered TigaTx.

Aldeyra Expects Mid-2025 Refiling Of Reproxalap After Second CRL

 
• By 

Aldeyra’s dry eye candidate reproxalap received a second FDA complete response letter, but the firm expressed confidence about refiling quickly based on two ongoing studies.

More from R&D

Epsilogen Hits Antibody Acquisition Trail With TigaTx Takeover

 
• By 

Following the near-total dominance of IgG antibodies, the UK group is backing the potential of IgA and IgE-based therapies to transform cancer treatment with the purchase of US-headquartered TigaTx.

What Is Fuelling Cell And Gene Therapies In India?

 
• By 

Bharat Biotech is the latest entrant in India’s cell and gene therapy space, joining majors like Intas Pharma, Sun Pharma, Cipla and Dr. Reddy’s. An indigenously developed CAR-T cell therapy launched last year, what is driving growing interest and success in cell and gene therapies?

Aldeyra Expects Mid-2025 Refiling Of Reproxalap After Second CRL

 
• By 

Aldeyra’s dry eye candidate reproxalap received a second FDA complete response letter, but the firm expressed confidence about refiling quickly based on two ongoing studies.