Takeda Gets FDA Nod For HyQvia In CIDP

The drug could become competitive with Argenx’s Vyvgart Hytrulo, but the market opportunity for the rare disease remains unclear due to continued diagnostic challenges.

Takeda announced the approval of HyQvia in CIDP • Source: Shutterstock

Takeda Pharmaceutical Co. Ltd.’s HyQvia (immune globulin infusion 10% [human]/recombinant human hyaluronidase) was approved by the US Food and Drug Administration for chronic inflammatory demyelinating polyneuropathy (CIDP), a rare disorder. The Japanese drug maker may soon find itself neck-and-neck in competition, however, against an up-and-coming European biotech company that produced positive data for a drug in the same disease last year.

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 New Products

J&J’s Imaavy Approval Is The Starting Line For Pipeline-In-A-Product Strategy

 

The company’s FcRn inhibitor nipocalimab was approved by the US FDA for generalized myasthenia gravis (gMG), where it will join a competitive market.

Pipeline Watch: Five Approvals And One Phase III Readout

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

UPDATED: Merck KGaA Seals SpringWorks Buy

 
• By 

The German group is paying $3.9bn to get hold of the US firm and its two approved products.

Akeso Wins US Approval For PD-1 Antibody In NPC, Partly On US Data

 

Akeso’s penpulimab will be the second to hit the US market for nasopharyngeal carcinoma, but the first to win FDA approval for the indication based on clinical findings in US patients.

More from Scrip

J&J’s Imaavy Approval Is The Starting Line For Pipeline-In-A-Product Strategy

 

The company’s FcRn inhibitor nipocalimab was approved by the US FDA for generalized myasthenia gravis (gMG), where it will join a competitive market.

In Brief: Merck To Invest $1bn In New US Biologics Production

 

Merck is investing $ 1bn in a Delaware facility to produce Keytruda and expand biologics manufacturing amid US tariff concerns.

Can European Biotech Survive And Thrive In Era Of Instability?

 

Europe's biopharma sector could suffer if the Trump administration incentivizes US investment but VC leaders believe the region can still thrive and potentially capitalize on instability elsewhere.