Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 September 2023
NewsHumanCOVID-19MedicinesReferrals
Nine new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended nine medicines for approval at its September 2023 meeting.
The CHMP recommended granting a marketing authorisation for Ebglyss (lebrikizumab), for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents.
A positive opinion was adopted for Finlee* (dabrafenib) for the treatment of glioma, a type of brain tumour that begins in glial cells, the cells that surround and support nerve cells.
The Committee gave a positive opinion for Vanflyta* (quizartinib), for the treatment of adult patients with diagnosed acute myeloid leukaemia, a cancer of the blood and bone marrow.
Yorvipath* (palopegteriparatide), a parathyroid hormone replacement therapy, received a positive opinion for the treatment of chronic hypoparathyroidism in adults. Hypoparathyroidism is a disorder in which the glands in the neck do not produce enough parathyroid hormone.
The committee granted a positive opinion for Zilbrysq* (zilucoplan) for the treatment of generalised myasthenia gravis in adults. This chronic autoimmune neuromuscular condition causes muscle weakness in different parts of the body.
The CHMP recommended granting a marketing authorisation for Zoonotic Influenza Vaccine Seqirus (surface antigen, inactivated, adjuvanted), for the active immunisation against H5N1 subtype of Influenza A virus. This is an informed consent application that 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.
The committee adopted a positive opinion for the biosimilar medicine Herwenda (trastuzumab) for the treatment of metastatic and early breast cancer and metastatic gastric cancer.
The CHMP recommended granting a paediatric-use marketing authorisation (PUMA) for Aqumeldi (enalapril maleate) for the treatment of heart failure, and a marketing authorisation for Catiolanze (latanoprost) for the reduction of elevated intraocular pressure. Both medicines were submitted in hybrid applications, which rely in part on the results of pre-clinical tests and clinical trials of an already authorised reference product and in part on new data.
Recommendations on extensions of therapeutic indication for 11 medicines
The committee recommended 11 extensions of indication for medicines that are already authorised in the European Union (EU): Adcetris, Enhertu, Kaftrio, Kalydeco, Keytruda, Nordimet, Olumiant, Pepaxti, Ryeqo,Takhzyro and Voxzogo.
Non-renewal of conditional marketing authorisations
The committee recommended not renewing the conditional marketing authorisation of two medicines: Translarna (ataluren), a medicine for treating patients with Duchenne muscular dystrophy (a genetic disorder characterised by the progressive loss of muscle), and BlenRep (belantamab mafodotin) a medicine used to treat multiple myeloma (a cancer of the bone marrow).
These CHMP opinions will now be forwarded to the European Commission (EC), which will issue a final legally binding decision applicable in all EU Member States.
Public health communications on Translarna and BlenRep are available in the grid below.
COVID-19 update
The CHMP has recommended authorising two adapted vaccines targeting the Omicron XBB.1.5 subvariant: an adapted Comirnaty vaccine that received a positive opinion on 30 August 2023 (for more information, see news announcement) and an adapted Spikevax vaccine recommended for approval during the present meeting of the CHMP (for more information, see news announcement).
Skycovion withdrew their application for the prevention of COVID-19 in individuals 18 years of age and older. A question-and-answer document is available in the grid below.
Withdrawals of applications
Three applications for marketing authorisation were withdrawn during their assessment: Lutholaz, for use in cancer patients to reduce the duration of neutropenia and prevent febrile neutropenia, Vivjoa, for the treatment and prevention of vulvovaginal candidiasis, and Skycovion (see above). Question-and-answer documents on these withdrawals are available in the grid below.
The marketing authorisation holder for Iclusig withdrew an application for the use of this medicine in the treatment of adults newly diagnosed with Philadelphia chromosome-positive acute lymphoblastic leukaemia, a type of blood cancer. A question-and-answer document on this withdrawal is available in the grid below.
Start of referral
The CHMP started a review of all available information on the benefits and risks of Mysimba (naltrexone / bupropion), a medicine used along with diet and exercise to help manage weight in adults. The review is carried out under Article 20 of Regulation (EC) No 726/2004. For more information, see the public health communication in the grid below.
The committee also started a referral procedure for Havrix (inactivated, adsorbed), a vaccine protecting against infections caused by hepatitis A virus. The aim of this referral is to harmonise the prescribing information across the various countries where the product is approved after several inconsistencies have been identified. This review is carried out under Article 30 of Regulation (EC) No 726/2004. For more information, see the public health communication in the grid below.
Agenda and minutes
The agenda of the September 2023 CHMP meeting is published on EMA's website. Minutes of the July 2023 CHMP meeting will be published in the coming weeks.
CHMP statistics
Key figures from the September 2023 CHMP meeting are represented in the graphic below.
*This product was designated as an orphan medicine during its development. Orphan designations are reviewed by EMA's Committee for Orphan Medicinal Products (COMP) at the time of approval to determine whether the information available to date allows maintaining the medicine’s orphan status and granting the medicine ten years of market exclusivity.
Positive recommendations on new medicines
| Name of medicine | Ebglyss |
|---|---|
| International non-proprietary name (INN) | lebrikizumab |
| Marketing-authorisation applicant | Almirall, S.A. |
| Therapeutic indication | Treatment of moderate-to-severe atopic dermatitis in adults and adolescents |
| More information | Ebglyss: Pending EC decision |
| Name of medicine | Finlee |
|---|---|
| INN | dabrafenib |
| Marketing-authorisation applicant | Novartis Europharm Limited |
| Therapeutic indication | Treatment of glioma |
| More information | Finlee: Pending EC decision |
| Name of medicine | Vanflyta |
|---|---|
| INN | quizartinib |
| Marketing-authorisation applicant | Daiichi Sankyo Europe GmbH |
| Therapeutic indication | Treatment of adult patients with diagnosed acute myeloid leukaemia (AML) |
| More information | Vanflyta: Pending EC decision |
| Name of medicine | Yorvipath |
|---|---|
| INN | palopegteriparatide |
| Marketing-authorisation applicant | Ascendis Pharma Bone Diseases A/S |
| Therapeutic indication | Parathyroid hormone replacement therapy indicated for the treatment of adults with chronic hypoparathyroidism |
| More information | Yorvipath: Pending EC decision |
| Name of medicine | Zilbrysq |
|---|---|
| INN | zilucoplan |
| Marketing-authorisation applicant | UCB Pharma S.A. |
| Therapeutic indication | Treatment of generalised myasthenia gravis in adults |
| More information | Zilbrysq : Pending EC decision |
| Name of medicine | Zoonotic Influenza Vaccine Seqirus |
|---|---|
| Common name | zoonotic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) |
| Marketing-authorisation applicant | Seqirus S.r.l. |
| Therapeutic indication | Active immunisation against H5 subtype of Influenza A virus |
| More information | Zoonotic Influenza Vaccine Seqirus : Pending EC decision |
Positive recommendation on new biosimilar medicine
| Name of medicine | Herwenda |
|---|---|
| INN | trastuzumab |
| Marketing-authorisation applicant | Sandoz GmbH |
| Therapeutic indication | Treatment of metastatic and early breast cancer and metastatic gastric cancer (MGC) |
| More information | Herwenda: Pending EC decision |
Positive recommendation on new hybrid medicine
| Name of medicine | Aqumeldi |
|---|---|
| INN | enalapril maleate |
| Marketing-authorisation applicant | Proveca Pharma Limited |
| Therapeutic indication | Treatment of heart failure |
| More information | Aqumeldi: Pending EC decision |
| Name of medicine | Catiolanze |
|---|---|
| INN | latanoprost |
| Marketing-authorisation applicant | Santen Oy |
| Therapeutic indication | Reduction of elevated intraocular pressure (IOP) |
| More information | Catiolanze: Pending EC decision |
Positive recommendations on extensions of indications
| Name of medicine | Adcetris |
|---|---|
| INN | brentuximab vedotin |
| Marketing-authorisation holder | Takeda Pharma A/C |
| More information | Adcetris: Pending EC decision |
| Name of medicine | Enhertu |
|---|---|
| INN | trastuzumab deruxtecan |
| Marketing-authorisation holder | Daiichi Sankyo Europe GmbH |
| More information | Enhertu: Pending EC decision |
| Name of medicine | Kaftrio |
|---|---|
| INN | ivacaftor / tezacaftor / elexacaftor |
| Marketing-authorisation holder | Vertex Pharmaceuticals (Ireland) Limited |
| More information | Kaftrio: Pending EC decision |
| Name of medicine | Kalydeco |
|---|---|
| INN | ivacaftor |
| Marketing-authorisation holder | Vertex Pharmaceuticals (Ireland) Limited |
| More information | Kalydeco: Pending EC decision |
| Name of medicine | Keytruda |
|---|---|
| INN | pembrolizumab |
| Marketing-authorisation holder | Merck Sharp & Dohme B.V. |
| More information | Keytruda: Pending EC decision |
| Name of medicine | Nordimet |
|---|---|
| INN | methotrexate |
| Marketing-authorisation holder | Nordic Group B.V. |
| More information | Nordimet: Pending EC decision |
| Name of medicine | Olumiant |
|---|---|
| INN | baricitinib |
| Marketing-authorisation applicant | Eli Lilly Nederland B.V. |
| More information | Olumiant: Pending EC decision |
| Name of medicine | Pepaxti |
|---|---|
| INN | melphalan flufenamide |
| Marketing-authorisation applicant | Oncopeptides AB |
| More information | Pepaxti: Pending EC decision |
| Name of medicine | Ryeqo |
|---|---|
| INN | relugolix / estradiol / norethisterone acetate |
| Marketing-authorisation applicant | Gedeon Richer Plc. |
| More information | Ryeqo: Pending EC decision |
| Name of medicine | Takhzyro |
|---|---|
| INN | lanadelumab |
| Marketing-authorisation applicant | Takeda Pharmaceuticals International AG Ireland Branch |
| More information | Takhzyro: Pending EC decision |
| Name of medicine | Voxzogo |
|---|---|
| INN | vosoritide |
| Marketing-authorisation applicant | BioMarin International Limited |
| More information | Voxzogo: Pending EC decision |
| Name of medicine | BlenRep |
|---|---|
| INN | belantamab mafodotin |
| Marketing-authorisation holder | GlaxoSmithKline (Ireland) Limited |
| More information | EMA recommends non-renewal of authorisation of multiple myeloma medicine Blenrep |
| Name of medicine | Translarna |
|---|---|
| INN | ataluren |
| Marketing-authorisation holder | PTC Therapeutics International Limited |
| More information | EMA recommends non-renewal of authorisation of Duchenne muscular dystrophy medicine Translarna |
| Name of medicine | Lutholaz |
|---|---|
| INN | pegfilgrastim |
| Marketing-authorisation applicant | YES Pharmaceutical Development Services GmbH |
| More information | Lutholaz: Withdrawn application |
| Name of medicine | Vivjoa |
|---|---|
| INN | oteseconazole |
| Marketing-authorisation applicant | Gedeon Richter Plc. |
| More information | Vivjoa: Withdrawn application |
| Name of medicine | Skycovion |
|---|---|
| INN | GBP510 |
| Marketing-authorisation applicant | SK Chemicals GmbH |
| More information | Skycovion: Withdrawn application |
| Name of medicine | Iclusig |
|---|---|
| INN | ponatinib |
| Marketing-authorisation holder | Incyte Biosciences Distribution B.V. |
| More information | Iclusig: Withdrawn application |
Start of referral
| Name of medicine | Mysimba |
|---|---|
| INN | naltrexone hydrochloride / bupropion hydrochloride |
| Marketing-authorisation holder | Orexigen Therapeutics Ireland Limited |
| More information | Mysimba: Article 20 referral |
| Name of medicine | Havrix |
|---|---|
| Common name | hepatitis A virus (inactivated, adsorbed) |
| Marketing-authorisation holder | GlaxoSmithKline Biologicals |
| More information | Havrix: Article 30 referral |