New EU Filings

Omaveloxolone, Reata Pharmaceuticals’s orphan drug for treating patients with Friedreich’s ataxia, is among the latest drugs that have been filed for review by the European Medicines Agency for potential EU marketing approval.

This is a regularly updated searchable list of products that have been filed with the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) under the EU's centralized authorization procedure. The information is based on the EMA's monthly updated list of medicines under review at the agency, CHMP monthly meeting agendas, company press releases, and original research by the Pink Sheet. 

The EMA's latest monthly filings list, which comprised data extracted on 5 January, included marketing authorization applications (MAAs) for nine new products. (Also see "Ophthalmic Bevacizumab & CRISPR-Based Gene Therapy Among Latest EU Filings" - Pink Sheet, 30 Jan, 2023.)

The EMA does not identify in its own list the sponsors of MAAs 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 sometimes 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 monthly list or the CHMP agenda is compiled.  

The Pink Sheet's table below includes the MAAs that have been validated by the EMA as well as those that were submitted but which had not yet been validated when the EMA's list in question was published.