EMA Prioritizes Three New Treatments as Part of its PRIME Scheme

Regulatory News | 19 October 2016 | By Zachary Brennan

The European Medicines Agency (EMA) on Wednesday announced that it recently granted eligibility to three new treatments as part of its PRIME scheme, which focuses on medicines that may offer a major therapeutic advantage over existing treatments or benefit patients without treatment options.

The newly added medicines, which are considered priority medicines by EMA, include Cymabay Therapeutics’ MBX-8025, which is intended to treat Primary Biliary Cholangitis, a chronic liver disease, Atara Bio’s Allogeneic Epstein-Barr virus-specific cytotoxic T lymphocytes (ATA129), which is intended to treat patients with Epstein-Barr virus-associated Post Transplant Lymphoproliferative Disorder in the allogeneic hematopoietic cell transplant setting who have failed on rituximab, and Albireo’s A4250, which is for the treatment of Progressive Familial Intrahepatic Cholestasis, which is also a liver disease.

The recommendations were made at EMA’s Committee for Medicinal Products for Human Use (CHMP) October 2016 meeting, during which the committee also denied six PRIME requests, including three oncology treatments.

An overview of the requests granted and denied under the PRIME scheme includes:

Once a candidate medicine has been selected for PRIME, EMA will:

• appoint a rapporteur from CHMP or from the Committee on Advanced Therapies (CAT) to provide continuous support and help to build knowledge ahead of a marketing authorization application
• organize a kick-off meeting with the CHMP/CAT rapporteur and a multidisciplinary group of experts so that they provide guidance on the overall development plan and regulatory strategy
• assign a dedicated point of contact
• provide scientific advice at key development milestones, involving additional stakeholders such as health-technology-assessment bodies, to facilitate quicker access for patients to the new medicine
• confirm potential for accelerated assessment at the time of an application for marketing authorization.

In July, EMA added four other medicines to the PRIME scheme, which is similar to the US Food and Drug Administration's breakthrough threapy program.

Recommendations on eligibility to PRIME scheme: Adopted at the CHMP meeting of 10-13 October 2016

PRIME: priority medicines