EU Accelerated Assessment Tracker
Executive Summary
Accelerated assessment requests at the European Medicines Agency.
The tracker below provides information on accelerated assessment requests relating to planned marketing authorization applications (MAAs) that are known to have come before the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for a decision since January 2018.
The latest additions relate to January and February 2019. They involve: Astellas Pharma Inc. and gilteritinib; [MSD] and V920; Nabriva Therapeutics PLC and lefamulin; Bayer AG and darolutamide; and Daiichi Sankyo Co. Ltd. and pexidartinib. Gilteritinib and pexidartinib have orphan status. (Also see "MSD, Astellas Keep Fingers Crossed For EU Fast-Track Status " - Pink Sheet, 30 Jan, 2019.)
Companies apply for fast-track review of their planned MAAs in the knowledge that around half of all such applications are rejected. (Also see "EU Accelerated Assessment Tracker 2018: Rejection Rates Remain High" - Pink Sheet, 28 Feb, 2019.)
The EMA says requests should be made at least two to three months before the MAA is submitted. It also strongly recommends that prospective applicants request a pre-submission meeting six to seven months before submission to prepare for evaluation under accelerated assessment.
Such meetings allow companies to discuss their proposal for accelerated assessment with the agency and rapporteurs from the CHMP and any other committees concerned, such as the Pharmacovigilance Risk Assessment Committee or the Committee for Advanced Therapies. After the rapporteurs have received the request, they produce a briefing note which includes their recommendation on whether accelerated assessment should be granted or not. The CHMP may request clarifications from the applicant. It then makes a decision based on the request, the justifications presented, and the recommendations of the rapporteurs. The decisions are taken at the CHMP's monthly meetings and details are listed in the meeting agendas.
The accelerated assessment mechanism can cut the time it takes the EMA to evaluate an MAA from up to 210 days to up to 150 days (not counting clock stops when applicants have to provide additional information). The EMA reserves accelerated assessment for drugs it believes to be of major public health interest, particularly from the point of view of therapeutic innovation.
The information in the tracker is based on CHMP meeting agendas and minutes and other EMA documents, company information and original research.
The outcomes of accelerated assessment requests are published in the minutes of the CHMP meeting at which the requests are decided on. It usually takes at least six weeks for CHMP meeting minutes to be published. Some companies choose to disclose the outcome in the interim, but many do not. Companies sometime submit their MAA before the minutes are issued, at which point it becomes clear whether or not they have been granted accelerated assessment.
Sodium oxybate was refused accelerated assessment at the May 2018 meeting of the CHMP but it continues to be listed incorrectly in the EMA’s list of products under review as being evaluated under the fast-track mechanism.
From the editors of Scrip Regulatory Affairs.