Ultragenyx Gets Second Drug Approval; Crysvita With Kyowa Hakko Kirin

Ultragenyx already has a sales team in place to market its second commercial drug Crysvita (burosumab) – partnered with Kyowa Hakko Kirin – following its April 17 FDA approval for the treatment of pediatric and adult patients with x-linked hypophosphatemia (XLH).

FDA Approved typed words on a vintage typewriter

Crysvita (burosumab), approved in the US for the treatment of x-linked hypophosphatemia (XLH) – a rare, inherited form of rickets – on April 17, is Ultragenyx Pharmaceutical Inc.'s second drug to reach the market, but this time around the company has a commercial team already in place and a partner.

Crysvita follows Ultragenyx's Mepsevii (vestronidase alfa-vjbk) onto the market five months after the recombinant version of the enzyme beta-glucuronidase won US FDA approval for the treatment of the rare genetic disease Mucopolysaccharidosis VII (MPS VII), also known as Sly syndrome

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

Pipeline Watch: Thirteen Approvals And Ten Phase III Readouts

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.

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.

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.

More from Scrip

BioNTech Aims To Diversify BNT323 Manufacturing As Filing Nears

 

The company plans to expand manufacturing of the HER2-targeting ADC beyond China and plans to file for US FDA approval in 2025.

Accelerated Approval May Be Out Of Reach For PTC’s Huntington’s Drug

 
• By 

PTC said its updated Phase II data for PTC 518 met the primary endpoint of Huntingtin’s protein reduction, but analysts said there isn’t clear correlation with clinical benefit.

Finance Watch: Unity Lays Off All Employees As It Evaluates Alternatives

 
• By 

Restructuring Edition: Unity unveiled more Phase IIb data for lead asset UBX1325 along with plans to shed its workforce while seeking a partner for it and other drugs. Also, Ono is consolidating US employees at one site, Entrada is cutting its workforce by 20% and other recent strategic shifts.