CSL's RiaSTAP approved in US for fibrinogen deficiency

The US FDA has granted accelerated approval of [C#198600617:CSL] Behring's clotting agent RiaSTAP (fibrinogen concentrate (human)) for the treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, an orphan indication that affects 150-300 people in the US.

The US FDA has granted accelerated approval of CSL Behring's clotting agent RiaSTAP (fibrinogen concentrate (human)) for the treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, an orphan indication that affects 150-300 people in the US.

The biological is indicated for patients with afibrogenaemia (absence or very low levels of plasma fibrinogen) and hypofibrinogaenemia (levels below...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Neurological

More from Therapeutic Category

BioMarin’s Roctavian Continues to Shine In Hemophilia A Despite Commercial Woes

 

Roctavian shows durable bleed control and safety over five years, but high costs and access hurdles limit its commercial outlook.

Novartis’s Cosentyx Suffers Rare Phase III Fail

 
• By 

Multi-blockbuster falls short in a giant cell arteritis study.

In Brief: 4DMT Fast-Tracks Long-Acting Wet AMD Therapy Trials, Cuts 25% Of Workforce

 

4D Molecular Therapeutics has fast-tracked its Phase III trials for 4D-150 in wet AMD, with top-line data from one now expected in H1 2027 and another underway ahead of schedule. The company is also cutting a quarter of its staff as it focuses on its late-stage pipeline and to help fund the trials.