EMA’s CHMP Recommends Five New Medicines for Approval

Posted 26 February 2018 | By Ana Mulero 

EMA’s CHMP Recommends Five New Medicines for Approval

Five new medicines, including two with orphan designations, have been recommended for marketing approval by the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).

The two with orphan designations were Ammtek’s Amiglidia (glibenclamide) for treating neonatal diabetes mellitus and Pfizer’s Mylotarg (gemtuzumab ozogamicin), indicated and acute myeloid leukemia.

Biocryst UK’s Alpivab (peramivir) for acute influenza treatment, as well as two medicines for treating chronic obstructive pulmonary disease – CHF 5993 Chiesi Farmaceutici S.p.A. (beclometasone dipropionate anhydrous / formoterol fumarate dihydrate / glycopyrronium) and Trydonis (beclometasone dipropionate anhydrous / formoterol fumarate dihydrate / glycopyrronium) – received the committee’s nod for marketing in the EU also.

CHMP also recommended granting an extension of indication to Swedish Orphan Biovitrum AB’s Kineret (anakinra) for the treatment of Still’s disease, a rare disease causing joint inflammation, as well as rash and fever, in children and adults. Six other positive recommendations included those on extending therapeutic indications, including for Pfizer’s Bosulif, Shield TX’s Feraccru, and Merck Sharp & Dohme’s Isentress. Negative opinions from CHMP came for Puma Biotechnology’s Nerlynx (neratinib) and for Pfizer’s Sutent (sunitinib).

The US Food and Drug Administration has approved Nerlynx – indicated for breast cancer, and Sutent’s indication of treating adult patients who are at a high risk of developing kidney cancer in 2017.

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 February 2018

Categories: Regulatory News

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