1. Pink Sheet
  2. >>Product Reviews

Roche Gets UK Early Access OK For New Hemophilia Drug

 
• By Vibha Sharma

The UK regulator is allowing patients to be treated with Roche’s as yet unlicensed hemophilia drug, emicizumab, under the country’s early access scheme. Hemlibra is already approved in the US and is in the final stages of review in the EU, where it is undergoing accelerated assessment.

RedBloodCellsOnWhite_1200x675
UK All Clear For Roche's Hemophilia Drug Emicizumab Under Early Access Scheme • Source: Shutterstock

The UK Medicines and Healthcare products Regulatory Agency is allowing Roche to make its promising new but as yet unlicensed hemophilia drug, Hemlibra (emicizumab), available to patients under the early access to medicines scheme (EAMS).

The UK's decision to allow patients early access to emicizumab comes as the drug is nearing the final stages of evaluation under the European Medicines Agency’s accelerated assessment mechanism. At its most recent meeting, in December, the EMA's human medicines evaluation committee, the CHMP, adopted a list of outstanding issues (LoOIs) regarding emicizumab's marketing authorization application

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 Product Reviews

More from Pink Sheet

Global Pharma Guidance Tracker - April 2025

 
• By Vibha Sharma and Anabel Costa-Ferreira

Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Medicare Negotiation Does Not Violate Due Process, Appeals Court Rules, Other Suits At Risk

 
• By Cathy Kelly

Decision in AstraZeneca’s lawsuit against the Health and Human Services Department is a precedent-setting victory for the government and a blow to manufacturer efforts to block the price negotiation program.

Keep Talking: US FDA’s Beleaguered Biologics Center Remains Vital To Regenerative Medicine

 
• By Bridget Silverman

Advisory committee for Capricor’s deriamocel planned, regenerative medicine advanced therapy designations proliferate for osteoarthritis, and the ranks of dual RMAT/breakthrough therapy designation holders grow.