BI Prepares For Regulatory Filings After Spevigo Successfully Prevents GPP Flares

In Phase IIb trial

The German firm’s Spevigo seems set to dominate the generalized pustular psoriasis market after it reduced the risk of flares in the pivotal EFFISAYIL 2 trial, triggering label expansion plans less than a year after it was approved for flare treatment.  

Blocks with drawn outlines of different organs on them
GPP Flares Can Lead To Sepsis, Shock And Organ Failure • Source: Shutterstock

Boehringer Ingelheim GmbH’s IL-36 inhibitor Spevigo has impressed in a pivotal trial for generalized pustular psoriasis (GPP) flare prevention with plans in place for regulatory filings later this year that could expand its current indication for flare treatment.

More from Clinical Trials

Compass’ Bispecific BTC Contender Meets Phase II/III Endpoint

 
• By 

Compass' bispecific antibody tovecimig hits primary efficacy endpoint in Phase II/III top-line data in advanced biliary tract cancer, and may have class side-effect advantages. But additional survival data may be needed to support US approval.

BeiGene Ends Anti-TIGIT Development In Lung Cancer

 
• By 

BeiGene’s Phase III ociperlimab joins the list of failed TIGIT inhibitors, as candidates from Roche, Merck & Co. and others have failed late-stage studies.

Edgewise’s HCM Candidate May Provide Advantages Over BMS’s Camzyos

 
• By 

With new Phase II data, Edgewise asserted that EDG-7500, a sarcomere modulator, could offer better efficacy and safety than cardiac myosin inhibitors in hypertrophic cardiomyopathy.

AbbVie On A STEAP Learning Curve In ADCs

 

Investing heavily in antibody-drug conjugates, AbbVie is pioneering a dual STEAP1xPSMA-targeting approach in prostate cancer, as other candidates advance.

More from R&D

AbbVie On A STEAP Learning Curve In ADCs

 

Investing heavily in antibody-drug conjugates, AbbVie is pioneering a dual STEAP1xPSMA-targeting approach in prostate cancer, as other candidates advance.

Boehringer Still Sees Plenty Of Juice In Jardiance

 
• By 

Strong sales growth for the German group’s SGLT2 inhibitor in 2024

Hengrui Renews Global Phase III Push As China Players Plan Pivotal Multinational Trials

 

After a more than three-year hiatus, China's Hengrui has signalled its return to multiregional Phase III trials as it looks to globalize its innovative pipeline. Meanwhile, a number of other Chinese players have announced plans to kick off Phase III trials this year and beyond.