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

News 23/02/2018

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 medicines1, 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. For more information, please see the press release in the grid below.

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: Riarify2 (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).

For more information on these negative opinions, please see the questions-and-answers documents in the grid below.

Six recommendations on extensions of therapeutic indication

The Committee also recommended extensions of indications for Bosulif, Feraccru, Isentress, Kineret, Lynparza and Xgeva.

A press release on the extension of indication for Kineret for the treatment of Still's disease in children and adults is available in the grid below.

Withdrawal of application

An application to extend the use of Zydelig (idelalisib) for the treatment of chronic lymphocytic leukaemia has been withdrawn. A questions-and-answers document on this withdrawal is available below.

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.

More information on all other outcomes of the CHMP February 2018 meeting is available in the grid below.


1As always at time of approval, these orphan designations will now be reviewed by EMA's Committee for Orphan Medicinal Products (COMP) to determine whether the information available to date allows maintaining the medicines' orphan status and granting the medicines ten years of market exclusivity.

2Previously known as CHF 5993 Chiesi Farmaceutici S.p.A.

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Positive recommendations on new medicines

Name of medicineAlpivab
International non-proprietary name (INN)peramivir
Marketing-authorisation applicantBiocryst UK Limited
Therapeutic indicationTreatment of uncomplicated influenza
More information PDF iconSummary of opinion for Alpivab

Name of medicineAmglidia
INNglibenclamide
Marketing-authorisation applicantAmmtek
Therapeutic indicationTreatment of neonatal diabetes
More information

PDF iconSummary of opinion for Amglidia


Press release: First medicine to treat neonatal diabetes

Name of medicineMylotarg
INNgemtuzumab ozogamicin
Marketing-authorisation applicantPfizer Limited
Therapeutic indicationTreatment of acute myeloid leukaemia
More information PDF iconSummary of opinion for Mylotarg

Positive recommendations on new informed-consent applications

Name of medicine Riarify (Previously known as CHF 5993 Chiesi Farmaceutici S.p.A.)
INNbeclometasone dipropionate anhydrous / formoterol fumarate dihydrate / glycopyrronium
Marketing-authorisation applicantChiesi Farmaceutici S.p.A.
Therapeutic indicationMaintenance treatment of adult patients with moderate to severe chronic obstructive pulmonary disease
More information PDF iconSummary of opinion for Riarify (Updated on 27/02/2018)

Name of medicineTrydonis
INNbeclometasone dipropionate anhydrous / formoterol fumarate dihydrate / glycopyrronium
Marketing-authorisation applicantChiesi Farmaceutici S.p.A.
Therapeutic indicationMaintenance treatment of adult patients with moderate to severe chronic obstructive pulmonary disease
More information PDF iconSummary of opinion for Trydonis

Negative recommendation on new medicine

Name of medicineNerlynx
INNneratinib
Marketing-authorisation applicantPuma Biotechnology Ltd
Therapeutic indicationTreatment of breast cancer
More information PDF iconQuestions and answers on Nerlynx

Positive recommendations on extensions of indications

Name of medicineBosulif
INNbosutinib
Marketing-authorisation holderPfizer Limited
More information PDF iconSummary of opinion for Bosulif

Name of medicineFeraccru
INNferric maltol
Marketing-authorisation holderShield TX (UK) Ltd
More information PDF iconSummary of opinion for Feraccru

Name of medicineIsentress
INNraltegravir
Marketing-authorisation holderMerck Sharp & Dohme Limited
More information PDF iconSummary of opinion for Isentress

Name of medicineKineret
INNanakinra
Marketing-authorisation holderSwedish Orphan Biovitrum AB (publ)
More information

PDF iconSummary of opinion for Kineret


Press release: New treatment option for rare inflammatory disease

Name of medicineLynparza
INNolaparib
Marketing-authorisation holderAstraZeneca AB
More information PDF iconSummary of opinion for Lynparza

Name of medicineXgeva
INNdenosumab
Marketing-authorisation holderAmgen Europe B.V.
More information PDF iconSummary of opinion for Xgeva

Negative recommendation on extension of indication

Name of medicineSutent
INNsunitinib
Marketing-authorisation holderPfizer Limited
More information PDF iconQuestions and answers on Sutent

Withdrawal of application for extension of indication

Name of medicineZydelig
INNidelalisib
Marketing-authorisation applicantGilead Sciences International Ltd.
More information PDF iconQuestions and answers on Zydelig

Other updates

PDF iconRecommendations on eligibility to PRIME scheme
PDF iconScientific advice and protocol assistance
Overview of (invented) names reviewed in January 2018 by the Name Review Group (NRG)

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