Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 July 2018

News 27/07/2018

Sixteen medicines recommended for approval, including two orphans

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended 16 medicines for approval, including two orphan medicines1, at its July 2018 meeting.

The Committee recommended granting a marketing authorisation for Onpattro (patisiran), for the treatment of hereditary transthyretin-mediated amyloidosis in adult patients with stage 1 or stage 2 polyneuropathy (a condition in which the peripheral nerves are damaged). This medicine was reviewed under EMA's accelerated assessment procedure, reserved for medicines of major public health interest. Onpattro was designated as an orphan medicine during its development. For more information, please see the press release in the grid below.

The CHMP recommended granting two new paediatric-use marketing authorisations (PUMAs), for Kigabeq (vigabatrin), for the treatment of infantile spasms (West's syndrome) and resistant partial epilepsy, and Slenyto (melatonin), for the treatment of insomnia in children and adolescents with autism spectrum disorder or Smith-Magenis syndrome. For more information, please see the press release in the grid below.

Symkevi (tezacaftor / ivacaftor) received a positive opinion for the treatment of cystic fibrosis. Symkevi was designated as an orphan medicine during its development.

The Committee adopted a positive opinion for Xerava (eravacycline), a new antibacterial medicine for the treatment of complicated intra-abdominal infections in adults.

The CHMP recommended granting marketing authorisations for four cancer medicines: Braftovi (encorafenib) and Mektovi (binimetinib), two medicines to be used in combination in the treatment of patients with unresectable or metastatic melanoma with a BRAF V600 mutation; Imfinzi (durvalumab), for the treatment of non-small cell lung cancer and Verzenios (abemaciclib), for the treatment of locally advanced or metastatic breast cancer.

Ilumetri (tildrakizumab) received a positive opinion for the treatment of moderate to severe plaque psoriasis.

Three biosimilar medicines received a positive opinion from the Committee: Hulio (adalimumab), for the treatment of certain inflammatory and autoimmune disorders; Pelgraz (pegfilgrastim) and Udenyca (pegfilgrastim), both intended to reduce the duration of neutropenia and the incidence of febrile neutropenia due to chemotherapy.

The CHMP recommended granting a marketing authorisation for three generic medicines: Deferiprone Lipomed (deferiprone), for the treatment of iron overload in patients with thalassaemia major; Gefitinib Mylan (gefitinib), for the treatment of non-small cell lung cancer and Lenalidomide Accord (lenalidomide), for the treatment of multiple myeloma.

Negative recommendations on new medicines following re-examination

The applicants for Dexxience (betrixaban) and Eladynos (abaloparatide) requested re-examinations of the Committee's negative opinions for these medicines adopted at the March 2018 meeting. After considering the grounds for these requests, the CHMP re-examined the initial opinions and confirmed its previous recommendations to refuse the granting of marketing authorisations for these medicines.

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

Twelve recommendations on extensions of therapeutic indication

The Committee recommended extensions of indication for Abseamed, Binocrit, Blincyto, Darzalex, Epoetin alfa Hexal, Kalydeco, Mekinist, Nucala, Tafinlar, Xarelto and two extensions of indication for Keytruda.

Negative opinions on extension of therapeutic indication

The CHMP adopted a negative opinion for the use of Opdivo (nivolumab) and Yervoy (ipilimumab) in combination to treat renal cell carcinoma (kidney cancer).

The Committee also adopted a negative opinion for an extension of therapeutic indication for Blincyto in patients with minimal residual disease after treatment for B-precursor acute lymphoblastic leukaemia.

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

Outcome of review on Xofigo

The CHMP recommended restricting the use of Xofigo (radium-223 dichloride) to patients who have had two previous treatments for metastatic prostate cancer or who cannot receive other treatments. For more information, please see the public health recommendation in the grid below.

Withdrawals of applications

The application for an initial marketing authorisation for Raligize (axalimogene filolisbac) was withdrawn. This medicine was intended to be used for the treatment of cervical cancer.

Applications to extend the use of Opdivo (nivolumab) to the treatment of stomach cancer and Sutent (sunitinib) to treat patients at high risk of kidney cancer returning after surgery have also been withdrawn.

Question-and-answer documents on these withdrawals are available in the grid below.

Agenda and minutes

The agenda of the July 2018 meeting is published on EMA's website. Minutes of the June 2018 CHMP meeting will be published in the coming weeks.

CHMP statistics

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


1 As 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.

 July 2018

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Positive recommendations on new medicines

Name of medicineBraftovi
INNencorafenib
Marketing-authorisation applicantPierre Fabre Medicament
Therapeutic indicationIn combination with binimetinib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation
More information PDF iconSummary of opinion for Braftovi

Name of medicineIlumetri
INNtildrakizumab
Marketing-authorisation applicantAlmirall S.A.
Therapeutic indicationTreatment of moderate to severe plaque psoriasis
More information PDF iconSummary of opinion for Ilumetri

Name of medicineImfinzi
INNdurvalumab
Marketing-authorisation applicantAstraZeneca AB
Therapeutic indicationTreatment of non-small cell lung cancer
More information PDF iconSummary of opinion for Imfinzi

Name of medicineMektovi
INNbinimetinib
Marketing-authorisation applicantPierre Fabre Medicament
Therapeutic indicationIn combination with encorafenib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation
More information PDF iconSummary of opinion for Mektovi

Name of medicineOnpattro
INNpatisiran
Marketing-authorisation applicantAlnylam Netherlands B.V.
Therapeutic indicationTreatment of hereditary transthyretin-mediated amyloidosis
More information

PDF iconSummary of opinion for Onpattro

Press release: New medicine for hereditary rare disease

Name of medicineSlenyto
INNmelatonin
Marketing-authorisation applicantRAD Neurim Pharmaceuticals EEC Ltd.
Therapeutic indicationTreatment of insomnia in children and adolescents with autism spectrum disorder or Smith-Magenis syndrome
More information

PDF iconSummary of opinion for Slenyto

Press release: Two new paediatric-use marketing authorisations recommended by CHMP

Name of medicineSymkevi
INNtezacaftor / ivacaftor
Marketing-authorisation applicantVertex Pharmaceuticals (Europe) Ltd.
Therapeutic indicationTreatment of cystic fibrosis
More information PDF iconSummary of opinion for Symkevi

Name of medicineVerzenios
INNabemaciclib
Marketing-authorisation applicantEli Lilly Nederland B.V.
Therapeutic indicationTreatment of locally advanced or metastatic breast cancer
More information PDF iconSummary of opinion for Verzenios

Name of medicineXerava
INNeravacycline
Marketing-authorisation applicantTetraphase Pharmaceuticals Ireland Limited
Therapeutic indicationTreatment of complicated intra-abdominal infections in adults
More information PDF iconSummary of opinion for Xerava

Positive recommendations on new generic medicines

Name of medicineDeferiprone Lipomed
INNdeferiprone
Marketing-authorisation applicantLipomed GmbH
Therapeutic indicationTreatment of iron overload in patients with thalassaemia major
More information PDF iconSummary of opinion for Deferiprone Lipomed

Name of medicineGefitinib Mylan
International non-proprietary name (INN)gefitinib
Marketing-authorisation applicantMylan S.A.S.
Therapeutic indicationTreatment of non-small cell lung cancer
More information PDF iconSummary of opinion for Gefitinib Mylan

Name of medicineLenalidomide Accord
International non-proprietary name (INN)lenalidomide
Marketing-authorisation applicantAccord Healthcare Limited
Therapeutic indicationTreatment of multiple myeloma
More information PDF iconSummary of opinion for Lenalidomide Accord

Positive recommendations on new biosimilar medicines

Name of medicineHulio
International non-proprietary name (INN)adalimumab
Marketing-authorisation applicantMylan S.A.S
Therapeutic indicationTreatment of certain inflammatory and autoimmune disorders
More information PDF iconSummary of opinion for Hulio

Name of medicinePelgraz
INNpegfilgrastim
Marketing-authorisation applicantAccord Healthcare Limited
Therapeutic indicationIntended to reduce the duration of neutropenia and the incidence of febrile neutropenia due to chemotherapy
More information PDF iconSummary of opinion for Pelgraz

Name of medicineUdenyca
INNpegfilgrastim
Marketing-authorisation applicantERA Consulting GmbH
Therapeutic indicationIntended to reduce the duration of neutropenia and the incidence of febrile neutropenia due to chemotherapy
More information PDF iconSummary of opinion for Udenyca

Positive recommendations on new hybrid medicine

Name of medicineKigabeq
INNvigabatrin
Marketing-authorisation applicantOrphelia Pharma SAS
Therapeutic indicationTreatment of infantile spasms (West's syndrome) and resistant partial epilepsy (focal onset seizures) in infants and children
More information

PDF iconSummary of opinion for Kigabeq

Press release: Two new paediatric-use marketing authorisations recommended by CHMP

Negative recommendation for new medicines following re-examination

Name of medicineDexxience
INNbetrixaban
Marketing-authorisation applicantPortola Pharma UK Limited
Therapeutic indicationPrevention of venous thromboembolism
More information PDF iconQuestions and answers on Dexxience

Name of medicineEladynos
INNabaloparatide
Marketing-authorisation applicantRadius International Ltd
Therapeutic indicationTreatment of osteoporosis
More information PDF iconQuestions and answers on Eladynos

Positive recommendations on extensions of indications

Name of medicineAbseamed
INNepoetin alfa
Marketing-authorisation holderMedice Arzneimittel Pütter GmbH & Co. KG
More information PDF iconSummary of opinion for Abseamed

Name of medicineBinocrit
INNepoetin alfa
Marketing-authorisation holderSandoz GmbH
More information PDF iconSummary of opinion for Binocrit

Name of medicineBlincyto
INNblinatumomab
Marketing-authorisation holderAmgen Europe B.V.
More information PDF iconSummary of opinion for Blincyto

Name of medicineDarzalex
INNdaratumumab
Marketing-authorisation holderJanssen-Cilag International NV
More information PDF iconSummary of opinion for Darzalex

Name of medicineEpoetin alfa Hexal
INNepoetin alfa
Marketing-authorisation holderHexal AG
More information PDF iconSummary of opinion for Epoetin alfa Hexal

Name of medicineKalydeco
INNivacaftor
Marketing-authorisation holderVertex Pharmaceuticals (Europe) Ltd
More information PDF iconSummary of opinion for Kalydeco

Name of medicineKeytruda
INNpembrolizumab
Marketing-authorisation holderMerck Sharp & Dohme B.V.
More information PDF iconSummary of opinion for Keytruda

Name of medicineMekinist
INNtrametinib
Marketing-authorisation holderNovartis Europharm Limited
More information PDF iconSummary of opinion for Mekinist

Name of medicineNucala
INNmepolizumab
Marketing-authorisation holderGlaxoSmithKline Trading Services Limited
More information PDF iconSummary of opinion for Nucala

Name of medicineTafinlar
INNdabrafenib
Marketing-authorisation holderNovartis Europharm Limited
More information PDF iconSummary of opinion for Tafinlar

Name of medicineXarelto
INNrivaroxaban
Marketing-authorisation holderBayer AG
More information PDF iconSummary of opinion for Xarelto

Recommendation for new contraindication

Name of medicineViekirax
INNombitasvir / paritaprevir / ritonavir
Marketing-authorisation holderAbbVie Deutschland GmbH & Co. KG
More information PDF iconSummary of opinion for Viekirax

Negative recommendations on extensions of indications

Name of medicineBlincyto
INNblinatumomab
Marketing-authorisation holderAmgen Europe B.V.
More information PDF iconQuestions and answers on Blincyto

Name of medicineOpdivo
INNnivolumab
Marketing-authorisation holderBristol-Myers Squibb Pharma EEIG
More information PDF iconQuestions and answers on Opdivo

Name of medicineYervoy
INNipilimumab
Marketing-authorisation holderBristol-Myers Squibb Pharma EEIG
More information PDF iconQuestions and answers on Yervoy

Public-health recommendation

Name of medicineXofigo
INNradium-223 dichloride
More informationEMA restricts use of prostate cancer medicine Xofigo

Withdrawal of initial marketing authorisation application

Name of medicineRaligize
INNaxalimogene filolisbac
Marketing-authorisation applicantFGK Representative Service GmbH
More information PDF iconQuestions and answers on Raligize

Withdrawal of extension of indication applications

Name of medicineOpdivo
INNnivolumab
Marketing-authorisation applicantBristol-Myers Squibb Pharma EEIG
More information PDF iconQuestions and answers on Opdivo

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

Other updates

PDF iconRecommendations on eligibility to PRIME scheme
PDF iconStart of community reviews
Scientific advice and protocol assistance

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