Five Drugs Set For EU Approval, Including Two Orphans

26 Feb 2018

• By Maureen Kenny

The EU’s CHMP has recommended approval of a number of products including Pfizer’s Mylotarg for acute myeloid leukemia, Ammtek’s Amglidia for neonatal diabetes, and BioCryst Pharmaceuticals/Seqirus’ Alpivab for uncomplicated influenza.

Yes, no, maybe — A number of products are awaiting a final approval decision in the EU • Source: Shutterstock

Five products including two with orphan designation are likely to secure pan-EU approval within the next couple of months, having received the thumbs up last week from the European Medicines Agency’s key advisory committee, the CHMP.

As expected, the committee recommended against the approval of Puma Biotechnology’s potential new breast cancer treatment, Nerlynx (neratinib). No...