1. Scrip
  2. >>New Products

Lutathera Approval Positions Novartis To Regain NET Share Taken By Ipsen

 
• By Eleanor Malone

The US FDA has approved Advanced Accelerator Applications' radiopharmaceutical Lutathera to treat GEP-NETs second time around, just four days after Novartis closed its acquisition of AAA. The product should help the Swiss firm regain ground its Sandostatin product has lost to Ipsen's Somatuline.

Product life cycle
Lutathera approval may help Novartis manage Sandostatin's market decline • Source: Shutterstock

Lutathera (lutetium Lu 177 dotatate) has won US FDA approval to treat somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The peptide receptor radionuclide therapy became the first product to be approved in the US this year, and the first radiopharmaceutical approved by the FDA to treat GEP-NETs, just four days after Novartis AG completed its purchase of the drug's developer, radiopharmaceutical specialist Advanced Accelerator Applications SA.

An Advanced Accelerator Applications spokeswoman said that the list price for Lutathera, which is classified as an orphan drug in...

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
Start Free Trial

Already a subscriber?

More from New Products

Pipeline Watch: ASCO Dominates 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.

Santen Sees Potential In Myopia Market After Ryjunea Approval

 
• By Kevin Grogan

The low-dose atropine eye drop slowed the progression of pediatric myopia by 30%.

Atai/Beckley Merger Comes At A Transformative Time For Psychedelics

 
• By Kevin Grogan

All eyes are on the upcoming readout of BPL-003 for treatment-resistant depression.

Stock Watch: How GSK’s Nucala Info Drip Helped Share Price

 
• By Andy Smith

The information flow in the months before the approval of GSK’s Nucala in COPD provides an interesting case study, and brings to mind the cautionary tale of Alnylam’s Onpattro.

More from Scrip

Spain’s SpliceBio Secures Sanofi and Roche Support In $135m Financing

 
• By Kevin Grogan

Series B cash will be used to advance its Stargardt disease gene therapy.

In Brief: PolyPid’s D-PLEX100 Aces Phase III Trial, US Partner, Submission Eyed

 
• By Sushmita Panda

PolyPid's D-PLEX100 meets Phase III endpoints this time around, significantly reducing surgical point infections in abdominal colorectal surgery, and is set for a US approval submission early next year.

Insmed’s PAH Data Indicate Potential To Surpass Established Therapies

 
• By Joseph Haas

Insmed’s inhaled treprostinil exceeded goals for reducing pulmonary vascular resistance and improving six-minute walk test distance in Phase IIb data.