EMA reports positive results of dialogue between developers, regulators and others

The leaders of several key European Medicines Agency (EMA) bodies have published a perspective piece showing their positive experiences of interacting early with developers of new drugs, and how this has helped accelerate patient access.

Martina Schussler-Lenz, Harald Enzmann and Spiros Vamvakas (the chairs of the Committee for Advanced Therapies – CAT – Committee for Human Medicinal Products – CHMP – and the head of Scientific Advice, respectively) have used the recent experience of Zynteglo to show the effect early interactions can have.

Zynteglo, for the rare disease beta-thalassemia, was entered into the EMA’s PRomising Innovative MEdicines (PRIME) scheme, and was able to put the enhanced dialogue with EMA to good use. EMA’s press release reports:

“These interactions led to a more robust application package to demonstrate the medicine’s benefits and risks, which allowed accelerated assessment. In the article, the authors describe some of the specific clinical and manufacturing process issues which were identified and how these were overcome. They also show that early accelerated approvals are only possible if a robust post-approval plan is defined at marketing authorisation stage.”

Read the EMA press release here, and the full article in open access through Clinical Pharmacology & Therapeutics.

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Published on 15. November 2019 in News, News UK