Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 February 2018
News
Human
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.
CHMP statistics: February 2018
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 | CHMP summary of positive opinion for Alpivab |
| Name of medicine | Amglidia |
|---|---|
| INN | glibenclamide |
| Marketing-authorisation applicant | Ammtek |
| Therapeutic indication | Treatment of neonatal diabetes |
| More information |
CHMP summary of positive opinion for Amglidia Press release: First medicine to treat neonatal diabetes |
| Name of medicine | Mylotarg |
|---|---|
| INN | gemtuzumab ozogamicin |
| Marketing-authorisation applicant | Pfizer Limited |
| Therapeutic indication | Treatment of acute myeloid leukaemia |
| More information | CHMP summary of positive 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 | CHMP summary of positive 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 | CHMP summary of positive 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 the positive opinion on the marketing authorisation for Nerlynx (neratinib) |
Positive recommendations on extensions of indications
| Name of medicine | Bosulif |
|---|---|
| INN | bosutinib |
| Marketing-authorisation holder | Pfizer Limited |
| More information | CHMP post-authorisation summary of positive opinion for Bosulif |
| Name of medicine | Feraccru |
|---|---|
| INN | ferric maltol |
| Marketing-authorisation holder | Shield TX (UK) Ltd |
| More information | CHMP post-authorisation summary of positive opinion for Feraccru |
| Name of medicine | Isentress |
|---|---|
| INN | raltegravir |
| Marketing-authorisation holder | Merck Sharp & Dohme Limited |
| More information | CHMP post-authorisation summary of positive opinion for Isentress |
| Name of medicine | Kineret |
|---|---|
| INN | anakinra |
| Marketing-authorisation holder | Swedish Orphan Biovitrum AB (publ) |
| More information |
CHMP post-authorisation summary of positive opinion for Kineret Press release: New treatment option for rare inflammatory disease |
| Name of medicine | Lynparza |
|---|---|
| INN | olaparib |
| Marketing-authorisation holder | AstraZeneca AB |
| More information |
| Name of medicine | Xgeva |
|---|---|
| INN | denosumab |
| Marketing-authorisation holder | Amgen Europe B.V. |
| More information | CHMP post-authorisation summary of positive opinion for Xgeva (II-55) |
Negative recommendation on extension of indication
| Name of medicine | Sutent |
|---|---|
| INN | sunitinib |
| Marketing-authorisation holder | Pfizer Limited |
| More information | Questions and answers on refusal of a change to the marketing authorisation for Sutent (sunitinib) |
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 the withdrawal of the application for a change to the marketing authorisation for Zydelig (idelalisib) |
Other updates
| Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 19-22 February 2018 |
| Scientific advice and protocol assistance adopted during the CHMP meeting 19 – 22 February 2018 |
| Overview of (invented) names reviewed in January 2018 by the Name Review Group (NRG) |