1. Scrip
  2. >>Business

Gilead’s RA Hopeful Filgotinib Hit By Complete Response Letter

FDA Concerned About High Dose And Testicular Side Effects

 
• By Andrew McConaghie

Complete Response Letter is a major setback for Gilead and its partner Galapagos.  

two hands of an elderly woman sitting on a chair - Image
• Source: Shutterstock

Gilead Sciences, Inc. has received a complete response letter (CRL) from the US Food and Drug Administration for filgotinib, its blockbuster prospect for rheumatoid arthritis, because of safety concerns.

The FDA has requested data from two pending clinical studies, MANTA and MANTA-RAy before completing its review of the drug, and has raised concerns about the drug’s potential impact on men’s

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 Business

Cipla Leadership’s Early Take On Trump’s Pricing EO And Pipeline Progress

 
• By Anju Ghangurde

Cipla's CEO underlines that US generic prices are already “very significantly comparable” with the rest of the world and expects President Donald Trump's executive order on drug pricing to primarily impact branded pharmaceuticals. The company also shared updates on its US pipeline.

Multiple Launches Help Lilly’s Japan Growth

 
• By Ian Haydock

Lilly saw solid growth for its business in Japan last year on the back of several new launches and is building its obesity and Alzheimer's portfolios in the country.

AbbVie Pays $335m Up Front To Partner With ADARx On siRNA Therapeutics

 
• By Mandy Jackson

ADARx CEO Zhen Li told Scrip the collaborators will advance novel siRNA medicines, but ADARx retains its clinical-stage and many preclinical programs and remains open to more deals.

Bluebird, Private Equity Firms Look To Sweeten Buyout Deal

 
• By Alaric DeArment

Shareholders are being offered a flat fee of $5 per share as an alternative to $3 plus a contingent value right, which could be a more attractive option if they want cash up front.

More from Scrip

Bluebird, Private Equity Firms Look To Sweeten Buyout Deal

 
• By Alaric DeArment

Shareholders are being offered a flat fee of $5 per share as an alternative to $3 plus a contingent value right, which could be a more attractive option if they want cash up front.

Novo Nordisk Looks To Septerna For Oral Obesity Options

 
• By Mary Jo Laffler

Deal Snapshot: The Danish drugmaker is partnering with GPCR drug discovery expert Septerna to develop multiple small molecules for cardiometabolic targets.

AbbVie On MFN: ‘We Have To Take It Seriously’

 
• By Jessica Merrill

AbbVie chief commercial officer Jeffrey Stewart called Trump’s drug pricing plan a “disruption” but said ultimately the delta between US and EU drug prices may not be as high as some expect.