Orphan AML Products Face CHMP Questioning

18 Sep 2019

• By Maureen Kenny

Companies developing new AML treatments are among those being called before the European Medicines Agency this week for questioning over marketing applications approaching the end of the review process.

Questions — The EMA has questions for companies about their marketing applications. • Source: Shutterstocks

More than half a dozen companies with marketing authorization applications in the later stages of the review process at the European Medicines Agency are due or potentially due to appear before the agency’s key scientific committee this week in an effort to address outstanding issues relating to their applications. Three of the products – all with orphan status – are for the treatment of acute myeloid leukemia (AML).

Oral explanations have formally been scheduled over the course of the September meeting of the Committee for Medicinal Products for...