Five medicines recommended for approval, including two orphans

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended five medicines for approval, including two orphan medicines, at its February 2018 meeting.

The CHMP recommended granting a marketing authorisation for Amglidia (glibenclamide), for the treatment of neonatal diabetes mellitus in newborns, infants and children. Because neonatal diabetes is a very rare disease, Amglidia was granted an orphan designation.

The cancer medicine Mylotarg (gemtuzumab ozogamicin) received a positive opinion for the treatment of acute myeloid leukaemia in patients aged 15 years and above, giving young patients a new treatment option. Mylotarg has an orphan designation.

The Committee recommended granting a marketing authorisation for Alpivab (peramivir), for the treatment of uncomplicated influenza.

The CHMP granted a positive opinion for two informed consent applications for the maintenance treatment of adult patients with moderate to severe 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).

An informed consent application makes use of data from the dossier of a previously authorised medicine, with the marketing authorisation holder of that medicine giving consent for the use of their data in the application.

Negative opinion on two medicines

The CHMP adopted a negative opinion for Nerlynx (neratinib). Nerlynx was expected to be used to treat breast cancer.

The CHMP also adopted a negative opinion for an extension of therapeutic indication for Sutent (sunitinib).

Six recommendations on extensions of therapeutic indication

The Committee also recommended extensions of indications for BosulifFeraccruIsentressKineretLynparza and Xgeva.

Withdrawal of application

An application to extend the use of Zydelig (idelalisib) for the treatment of chronic lymphocytic leukaemia has been withdrawn.

Agenda and minutes

The agenda of the February 2018 meeting is published on EMA’s website. Minutes of the January 2018 CHMP meeting will be published in the coming weeks.

CHMP statistics

Key figures from the February 2018 CHMP meeting are represented in the graphic below.

Posted on the EMA website on 23 February 2018