New Filings At The EMA
Executive Summary
New medicines under evaluation at the European Medicines Agency.
Shire/Takeda Pharmaceutical’s lifitegrast for treating dry eye disease is among the four new additions to the Pink Sheet's regularly updated list of products that are being evaluated by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) under the EU's centralized authorization procedure. The other three new additions are AstraZeneca’s triple combination therapy, budesonide/glycopyrronium/formoterol (fumarate dihydrate) (PT010), for chronic obstructive pulmonary disease, and two generic drugs: arsenic trioxide, an antineoplastic medicine, and dexmedetomidine, a psycholeptic.
The information in our list is based on the list of new medicines under review at the EMA that the agency updates every month, CHMP monthly meeting agendas, company press releases, and original research by the Pink Sheet.
The EMA does not identify in its own list the sponsors of marketing authorization applications that are under review. It gives only the international non-proprietary name (INN) and therapeutic area. For generic and biosimilar medicines, it provides the INN (active moiety only, with no information on salt, ester or derivative) and therapeutic area. The CHMP monthly meeting agendas identify the name of sponsors of orphan drugs only.
The EMA only lists information on medicines whose applications have been validated at the time the list in question or CHMP agenda is compiled. Its latest list was compiled on Jan. 7 and its latest CHMP agenda was published on Jan. 28.
Information on CHMP opinions and on EU approvals can be found elsewhere in the EU Performance Tracker section of the Pink Sheet website.
Information on the different types of applications or approval pathways involved – for example, accelerated assessment, informed consent application, conditional approval – is provided in footnotes below the table. In the EMA's latest list, for example, five products are being reviewed under the agency's accelerated assessment procedure, meaning that the CHMP will review the MAA within 150 days (not counting clock stops when applicants have to provide additional information) compared with the standard 210-day time frame (again not counting clock stops). These products are Theratechnologies Inc./TaiMed Biologics's ibalizumab, bluebird bio's LentiGlobin, Daiichi Sankyo Europe's quizartinib, Loxo Oncology's larotrectinib and AveXis's onasemnogene abeparvovec. (Also see "EU Accelerated Assessment Tracker: Nine Definites So Far From 24 Requests In 2018 " - Pink Sheet, 10 Jan, 2019.)
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