Travere Hopes For FDA Full Approval Despite Filspari Trial Endpoint Miss

 
• By Alaric DeArment
  
Generate a summary of this article
Listen to this article
Beta

The company said the “totality of data” from the confirmatory PROTECT trial in IgA nephropathy showed the drug slowed decline in kidney function.

Travere announced data from the Phase III PROTECT study of Filspari in IgA nephropathy • Source: Shutterstock

Travere Therapeutics, Inc. is optimistic about getting full approval for Filspari (sparsentan) in immunoglobulin A nephropathy (IgAN) based on results from the confirmatory Phase III PROTECT trial, anticipating that the US Food and Drug Administration will take the “totality of data” into account despite the trial not reaching statistical significance on its primary endpoint.

On 21 September, Travere announced the results for PROTECT, which compared Filspari against the generic drug irbesartan in IgAN patients....

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.

SpotifyApple PodcastsWebsite

More from Clinical Trials

Sciwind Eyes Differentiation For Ecnoglutide In Highly Competitive Arena

 
• By Xu Hu

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 Xu Hu

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

Scrip-R&D-Premium: ‘Article’ article that includes different Composer content

 
• By Nabil, Olga Zviezdicheva, Reed Miller, Mary Jo Laffler, Ian Schofield, João Andrés-Ruíz de la Fontaine-LeBlanc, Chloë Anastasía-Stojanović del Castillo-Ribeirão, and Nabil

To make your document look professionally produced, Word provides header, footer, cover page, and text box designs that complement each other. For example, you can add a matching cover page, header, and sidebar. Click Insert and then choose the elements you want from the different galleries.

Spotlight On RDCs, AOCs As Leading Novel Bioconjugates[Updated]

Pipelines in bioconjugates continue to develop, from ADCs to XDCs, with radionuclide drug conjugates (RDCs) and antibody-oligonucleotide conjugates (AOCs) leading the expansion.

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.