EU Accelerated Assessment Tracker

Marinus’s ganaxolone has lost its accelerated assessment status mid-review at the European Medicines Agency while Roche’s glofitamab will be fast-tracked once a filing has been made.

This tracker provides information on accelerated assessment requests for planned marketing authorization applications (MAAs) that have come before the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for a decision. It also tracks whether companies retain fast-track status for MAAs as they make their way through the EU centralized drug evaluation procedure.

This latest update (see table at the end of this article) reflects recent developments.

Specifically it records the fact that the MAA for ganaxolone, Marinus Pharmaceuticals’ potential treatment for seizures associated with CDKL5 deficiency disorder, has lost its accelerated assessment status and has reverted to standard review timelines.

It also records the fact that Roche has asked the EMA to fast-track its planned MAA for glofitamab, in development for the treatment of relapsed or refractory (r/r) diffuse large B-cell lymphomas (DLBCL), high grade B cell lymphoma and primary mediastinal large B-cell lymphoma. 

Ganaxolone Loss

The MAA for ganaxolone reverted to standard review timelines in January but the EMA only recorded the development in late March. The review of the MAA began in late October 2021.

The company has said it expects an opinion from the CHMP on whether the MAA should be recommend for approval by the end of the year.

Ganaxolone was approved as Ztalmy in the US in March.  (Also see "Marinus, With Ztalmy Approval, Takes First Step Into Seizure Disorder Market" - Scrip, 21 Mar, 2022.)  (Also see "Keeping Track: Marinus’ Ztalmy Continues US FDA’s Orphan Streak; AZ Gets Adjuvant Nod For Lynparza, Fasenra CRL" - Pink Sheet, 18 Mar, 2022.)

Three Requests in 2022

Three accelerated assessment requests have been decided on in the year to date. None of the outcomes appears yet to be in the public domain. The CHMP decided on Roche's glofitamab request at its March 2022 meeting. Roche declined to comment on the outcome.

The tracker does not include products that were fast-tracked under special regulatory provisions relating to the coronavirus pandemic.

 

Eight MAAs Under Speedy Review

The CHMP decides whether an MAA will be evaluated under accelerated or standard review timelines before the MAA is filed. When an accelerated assessment request reaches the stage of being listed for a decision on the agenda of a CHMP monthly meeting, it is usually a sign that an MAA filing will be made in the following few months.

Eight MAAs are currently being fast-tracked through the system. Seven are recorded in the EMA's latest monthly list of MAAs under review at the agency and one has been filed in the interim.

The latest list was originally published on 11 March (data extracted by the EMA on 3 March). The EMA published a corrected version on 23 March to reflect the ganaxolone development. An MAA for etranacogene dezaparvovec (EtranaDez), CSL Behring/UniQure’s novel gene therapy candidate for the treatment of hemophilia B, has been filed since the updated list was published.

The Process

The CHMP decides whether an MAA will be evaluated under accelerated or standard review timelines before the MAA is filed. When an accelerated assessment request reaches the stage of being listed for a decision on the agenda of a CHMP monthly meeting, it is usually a sign that an MAA filing will be made in the following few months.

The accelerated assessment mechanism is reserved for drugs of potential major public health interest, particularly from the point of view of therapeutic innovation. It can cut the time it takes the EMA to evaluate an MAA under the EU centralized procedure from up to 210 days to up to 150 days (not counting clock stops when applicants have to provide additional information). In practice, it can cut months off the approximately 12 months it generally takes to review an application at the EMA under standard EU centralized drug evaluation procedure timelines. 

The outcomes of accelerated assessment requests are published in the minutes of the CHMP meeting at which the requests are decided on. It takes at least six weeks for CHMP meeting minutes to be published. Some companies choose to disclose the outcome in the interim, but most do not. Companies sometimes submit their MAA before the minutes are issued, at which point it usually becomes clear whether or not they have been granted accelerated assessment.