Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 February 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 medicine	Alpivab
International non-proprietary name (INN)	peramivir
Marketing-authorisation applicant	Biocryst UK Limited
Therapeutic indication	Treatment of uncomplicated influenza
More information	Summary of opinion for Alpivab

Name of medicine	Mylotarg
INN	gemtuzumab ozogamicin
Marketing-authorisation applicant	Pfizer Limited
Therapeutic indication	Treatment of acute myeloid leukaemia
More information	Summary 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.)
INN	beclometasone dipropionate anhydrous / formoterol fumarate dihydrate / glycopyrronium
Marketing-authorisation applicant	Chiesi Farmaceutici S.p.A.
Therapeutic indication	Maintenance treatment of adult patients with moderate to severe chronic obstructive pulmonary disease
More information	Summary of opinion for Riarify (Updated on 27/02/2018)

Name of medicine	Trydonis
INN	beclometasone dipropionate anhydrous / formoterol fumarate dihydrate / glycopyrronium
Marketing-authorisation applicant	Chiesi Farmaceutici S.p.A.
Therapeutic indication	Maintenance treatment of adult patients with moderate to severe chronic obstructive pulmonary disease
More information	Summary of opinion for Trydonis

Negative recommendation on new medicine

Name of medicine	Nerlynx
INN	neratinib
Marketing-authorisation applicant	Puma Biotechnology Ltd
Therapeutic indication	Treatment of breast cancer
More information	Questions and answers on Nerlynx

Positive recommendations on extensions of indications

Name of medicine	Bosulif
INN	bosutinib
Marketing-authorisation holder	Pfizer Limited
More information	Summary of opinion for Bosulif

Name of medicine	Feraccru
INN	ferric maltol
Marketing-authorisation holder	Shield TX (UK) Ltd
More information	Summary of opinion for Feraccru

Name of medicine	Isentress
INN	raltegravir
Marketing-authorisation holder	Merck Sharp & Dohme Limited
More information	Summary of opinion for Isentress

Name of medicine	Lynparza
INN	olaparib
Marketing-authorisation holder	AstraZeneca AB
More information	Summary of opinion for Lynparza

Name of medicine	Xgeva
INN	denosumab
Marketing-authorisation holder	Amgen Europe B.V.
More information	Summary of opinion for Xgeva

Negative recommendation on extension of indication

Name of medicine	Sutent
INN	sunitinib
Marketing-authorisation holder	Pfizer Limited
More information	Questions and answers on Sutent

Withdrawal of application for extension of indication

Name of medicine	Zydelig
INN	idelalisib
Marketing-authorisation applicant	Gilead Sciences International Ltd.
More information	Questions and answers on Zydelig

Other updates

Recommendations on eligibility to PRIME scheme

Scientific advice and protocol assistance

Overview of (invented) names reviewed in January 2018 by the Name Review Group (NRG)