1. Scrip
  2. >>Business
  3. >>Strategy

J&J Immunology Growth Now Hinges On Stelara, Tremfya After RA Setback

 
• By Jessica Merrill

The company said it will pull global regulatory filings for the interleukin-6 inhibitor sirukumab for rheumatoid arthritis after determining regulatory delays would put it too far behind the competition.

business card

Johnson & Johnson's pharmaceutical unit remains on track to drive above-market compound annual growth through 2021, even without one of the new drugs the diversified pharma had hoped to have on the market, Worldwide Chairman-Pharmaceuticals Joaquin Duato assured investors during the company's third quarter sales and earnings call Oct. 17.

J&J announced in its quarterly release that it would withdraw global regulatory filings for the interleukin-6 inhibitor sirukumab for rheumatoid arthritis after the drug received a complete response letter from the US FDA in September. (Also see "Keeping Track: An RMAT, Two QIDPs, And Some Bad News Too" - Pink Sheet, 24 September, 2017.) The decision followed a vote against approval by the agency's Arthritis Advisory Committee in August over concerns about a mortality imbalance in clinical trials

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 Strategy

Aldeyra Plans To File Reproxalap Again With New Dry Eye Symptom Data

 
• By Joseph Haas

The biotech hopes a third time will be the charm after two FDA complete responses, with plans to position its eye drop as offering quicker onset of action.

Deal Watch: Lilly Looks To Creyon For Oligonucleotides

 
• By Joseph Haas

Plus deals involving J&J/Addex/Sinntaxis, Concentra/Kronos, Granata/Oviva, Coeptis/Z Squared, Ligand/Channel and more.

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

 
• By Joseph Haas

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.

AstraZeneca COPD Drug Breztri Breezes Through Asthma Trials

 
• By Kevin Grogan

The triple therapy improves lung function in the Phase III KALOS and LOGOS studies

More from Business

Deal Watch: Lilly Looks To Creyon For Oligonucleotides

 
• By Joseph Haas

Plus deals involving J&J/Addex/Sinntaxis, Concentra/Kronos, Granata/Oviva, Coeptis/Z Squared, Ligand/Channel and more.

BioNTech Aims To Diversify BNT323 Manufacturing As Filing Nears

 
• By Alaric DeArment

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 Joseph Haas

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.