Novartis Draws Out Its APPLAUSE

Another data drop from Fabhalta’s IgAN trial looks encouraging, despite a missing abstract.    

applause

Novartis AG is drip-feeding data from its APPLAUSE-IgAN trial. The study, assessing the oral complement factor B inhibitor Fabhalta (iptacopan) in IgA nephropathy (IgAN), was toplined a success in October. Now the company has revealed the finding on one of the two co-primary endpoints, saying that Fabhalta-treated patients achieved a statistically significant (p<0.0001) reduction="" in="">

The data come from a pre-specified interim analysis comprising 250 patients for the efficacy analysis and 443 for the safety...

Scrip Podcast

Keep up with the top pharma business news of the week. On the go.

Scrip brings you a weekly bulletin of top picks.

More from Clinical Trials

  • Sciwind Eyes Differentiation For Ecnoglutide In Highly Competitive Arena

     
    • By 

    Chinese firm Sciwind has revealed additional Phase III findings for its promising once-weekly GLP-1 agonist ecnoglutide, just one asset in a burgeoning Chinese sector that could see the emergence of new rivals to current global leaders in obesity and diabetes.

  • Fosun ALK/ROS1 Inhibitor Shows 1L Promise In Advanced NSCLC

     
    • By 

    Interim results from the Phase III REMARK study presented at WCLC showed the Chinese company’s second-generation ALK/ROS1 inhibitor met its primary endpoint as a first-line therapy in ALK-positive advanced NSCLC.

  • Sponsored By:

    Nancy Tests SPARC-931-part

    The article discusses the impact of upcoming patent expirations in oncology biologics on biosimilar developers, highlighting the opportunities in Antibody-Drug Conjugates (ADCs) and Bispecific Antibodies (BsAbs). It explores the challenges posed by the structural complexities of these biologics, necessitating new bioanalytical tools and manufacturing processes. The evolving regulatory landscape, with contributions from EMA, FDA, and WHO, offers flexible pathways but also presents challenges. The article underscores the potential for biosimilars to generate significant cost savings and enhance patient access to cancer treatments over the next decade.

  • Fosun ALK/ROS1 Inhibitor Shows 1L Promise In Advanced NSCLC

    Interim results from the Phase III REMARK study presented at WCLC showed the Chinese company’s second-generation ALK/ROS1 inhibitor met its primary endpoint as a first-line therapy in ALK-positive advanced NSCLC.

More from R&D