Orphan Drugs Dominate EU Fast-Track Request Decisions In July

28 Jul 2021

• By Maureen Kenny

The European Medicines Agency decided this month whether to grant fast-track review for planned marketing authorization applications for three potential new orphan treatments.

The accelerated assessment pathway can help get drugs to market faster • Source: Alamy

The European Medicines Agency was due to decide last week whether to grant fast-track status to the planned EU marketing authorization applications (MAAs) for four potential new treatments.* All but one of the four products have orphan status; filings for approval are likely to be submitted within the next few months.

The orphan products whose sponsors are seeking EU accelerated assessment are as follows: