1. Pink Sheet
  2. >>Drug Safety

EMA Reviewing Cardiovascular & Cancer Risk From Five Janus Kinase Inhibitors

 
• By Neena Brizmohun

The European Medicines Agency has been asked to make a recommendation by 30 September on whether the marketing authorization for the products concerned should be maintained, varied, suspended or revoked.

Wooden blocks with the word Review. Customer review concept. Reviewing, auditing, reviewer. Service rating. Feedback.
A review into the safety of five JAK inhibitors has started • Source: Alamy

The European Medicines Agency is starting to review the safety of five EU-approved Janus kinase (JAK) inhibitors that are used to treat chronic inflammatory disorders, due to concerns over an increased risk of developing a cardiovascular problem and cancer.

The safety review will focus on Xeljanz (tofacitinib) and Cibinqo (abrocitinib), both from Pfizer, and Jyseleca (filgotinib), Olumiant (baricitinib)...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet 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 Drug Safety

Titanium Dioxide Stays: EU Decides Not To Pull Plug On Widely Used Excipient

 
• By Neena Brizmohun

While titanium dioxide is banned as a food additive in the EU, the European Medicines Agency has convinced the European Commission to allow its continued use in the many thousands of medicines in which it is currently used.

New EU Drug Safety Rules Scrap Signal Detection Pilot, Boost Audit & Subcontracting Controls

 
• By Vibha Sharma

The European Commission has adopted new rules to cut red tape in pharmacovigilance, tighten oversight of outsourced drug safety activities, and ensure a balanced approach to signal detection, boosting both efficiency and patient safety.

Sarepta Will Resume US Elevidys Shipments For Ambulatory DMD Patients After FDA Reverses Course

 
• By Mandy Jackson

The FDA recommended removal of a voluntary hold on shipments of the gene therapy to younger patients after finding that the death of an 8-year-old boy in Brazil was unrelated to Elevidys. Discussions on safety of DMD treatment for non-ambulatory patients is ongoing.

Base Benefit-Risk Decisions On Data, Not Opinion And Passion, CDER’s Tidmarsh Says

 
• By Sue Sutter

New US FDA drugs center director George Tidmarsh’s data-centric comments at a Reagan-Udall Foundation meeting on unapproved fluoride products could suggest patients’ and caregivers’ experiences will carry less weight in benefit-risk decisions under his leadership.

More from Pink Sheet

England: Pharma Firms To Benefit From Parallel HTA And Regulatory Pathway

 
• By Eliza Slawther

The UK drug regulator and England’s health technology assessment agency have joined forces under an information sharing agreement, aimed at accelerating patient access to newly approved medicines by three to six months.

UK Medicines Shortages Inquiry Eyes Full Reshoring of Drug Manufacturing

 
• By Neena Brizmohun

A newly launched UK government inquiry is seeking to learn how viable it would be to bring back domestic control over the entire drug manufacturing pipeline.

Sponsored by:

A Crossroads for Global Health: Strengthening the Future of Vaccines

Learn how advances in vaccine adjuvants are shaping the future of global health and driving more effective immunization strategies