Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11 to 14 September 2017

News 15/09/2017

Thirteen medicines recommended for approval, including one orphan medicine

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended thirteen medicines for approval at its September meeting.

The CHMP recommended granting marketing authorisations for two cancer medicines: Zejula (niraparib), an orphan designated medicine intended for the treatment of ovarian cancer, and Tookad (padeliporfin), for the treatment of adenocarcinoma of the prostate.

Two medicines for the treatment of adults with moderate to severe chronic obstructive pulmonary disease also received a positive opinion from the Committee: Elebrato Ellipta (fluticasone furoate / umeclidinium / vilanterol) and Trelegy Ellipta (fluticasone furoate / umeclidinium / vilanterol).

CHMP gave positive opinions for two medicines for people using opioids: Nyxoid (naloxone), intended for the treatment of opioid overdose, and Zubsolv (buprenorphine / naloxone), intended for the treatment of opioid dependence. Hybrid applications were submitted for both medicines. This means that the marketing authorisation applications relied in part on the results of pre-clinical tests and clinical trials for a reference product and in part on new data.

The CHMP adopted a positive opinion for Tremfya (guselkumab) for the treatment of plaque psoriasis.

VeraSeal (human fibrinogen / human thrombin) received a positive opinion for use as a sealant during surgical operations in adults.

Two biosimilar medicines were recommended for approval by the Committee: Cyltezo (adalimumab) for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, paediatric plaque psoriasis, hidradenitis suppurativa, Crohn's disease, ulcerative colitis and uveitis; and Ontruzant (trastuzumab) for the treatment of early and metastatic breast cancer, and metastatic gastric cancer. Ontruzant is the first trastuzumab biosimilar recommended for approval by the CHMP.

Three generic medicines received a positive opinion from the CHMP: Imatinib Teva B.V. (imatinib) for the treatment of leukaemia and gastrointestinal stromal tumours; Miglustat Gen.Orph (miglustat) for the treatment of mild to moderate type 1 Gaucher disease; and Ritonavir Mylan (ritonavir) for the treatment of HIV infection.

Outcome of re-examination of three negative recommendations

The applicants for Adlumiz (anamorelin hydrochloride), Human IgG1 monoclonal antibody specific for human interleukin-1 alpha XBiotech (human IgG1 monoclonal antibody specific for human interleukin-1 alpha) and Masipro (masitinib) requested re-examinations of the Committee's negative opinions for these medicines adopted at the May 2017 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 questions-and-answers documents in the grid below.

Three recommendations on extensions of therapeutic indications

The Committee recommended extensions of indications for Tasigna, Firazyr and Stribild.

Negative opinion on one extension of therapeutic indication

The CHMP adopted a negative opinion for an extension of therapeutic indication for Raxone.

Outcome of review on factor VIII

The CHMP concluded that there is no clear and consistent evidence of a difference in the incidence of inhibitor development between the two classes of factor VIII medicines: those derived from plasma and those made by recombinant DNA technology. For more information please see the public health communication in the grid below.

Withdrawals of applications

Applications for initial marketing authorisations for Fulphila (pegfilgrastim), Ogivri (trastuzumab) and Tigecycline Accord (tigecycline) have been withdrawn.

Fulphila was intended to be used for reducing neutropenia in patients taking cancer treatments. Ogivri was intended to be used to treat breast and gastric cancers. Tigecycline Accord was intended to be used to treat certain complicated infections.

An application to extend the indication of Opdivo (nivolumab) to treat liver cancer has also been withdrawn.

Questions-and-answers documents on these withdrawals are available in the grid below.

Agenda and minutes

The agenda of the September 2017 meeting is published on EMA's website. Minutes of the July 2017 CHMP meeting will be published in the coming weeks.

CHMP statistics

Key figures from the September 2017 CHMP meeting are presented in the graphic below.

More information on all other outcomes of the CHMP September 2017 meeting is available in the grid below.

 September 2017

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Positive recommendations on new medicines

Name of medicineElebrato Ellipta
International non-proprietary name (INN)fluticasone furoate / umeclidinium / vilanterol
Marketing-authorisation applicantGlaxoSmithKline Trading Services
Therapeutic indicationTreatment of adults with moderate to severe chronic obstructive pulmonary disease
More information PDF iconSummary of opinion for Elebrato Ellipta

Name of medicineTremfya
INNguselkumab
Marketing-authorisation applicantJanssen-Cilag International N.V.
Therapeutic indicationTreatment of plaque psoriasis
More information PDF iconSummary of opinion for Tremfya

Name of medicineNyxoid
INNnaloxone
Marketing-authorisation applicantMundipharma Corporation Limited
Therapeutic indicationTreatment of opioid overdose
More information PDF iconSummary of opinion for Nyxoid

Name of medicineTookad
INNpadeliporfin
Marketing-authorisation applicantSTEBA Biotech S.A.
Therapeutic indicationTreatment of adenocarcinoma of the prostate
More information PDF iconSummary of opinion for Tookad

Name of medicineTrelegy Ellipta
INNfluticasone furoate / umeclidinium / vilanterol
Marketing-authorisation applicantGlaxoSmithKline Trading Services
Therapeutic indicationTreatment of adults with moderate to severe chronic obstructive pulmonary disease
More information PDF iconSummary of opinion for Trelegy Ellipta

Name of medicineVeraSeal
INNhuman fibrinogen/human thrombin
Marketing-authorisation applicantInstituto Grifols, S.A.
Therapeutic indicationUse as a sealant during surgical operations in adults
More information PDF iconSummary of opinion for VeraSeal

Name of medicineZejula
INNniraparib
Marketing-authorisation applicantTesaro UK Limited
Therapeutic indicationTreatment of ovarian cancer
More information PDF iconSummary of opinion for Zejula

Name of medicineZubsolv
INNbuprenorphine / naloxone
Marketing-authorisation applicantMundipharma Corporation Limited
Therapeutic indicationTreatment of opioid dependence
More information PDF iconSummary of opinion for Zubsolv

Positive recommendations on new generic medicines

Name of medicineImatinib Teva B.V.
INNimatinib
Marketing-authorisation applicantTeva B.V.
Therapeutic indicationTreatment of leukaemia and gastrointestinal stromal tumours
More information PDF iconSummary of opinion for Imatinib Teva B.V.

Name of medicineMiglustat Gen.Orph
INNmiglustat
Marketing-authorisation applicantGen.Orph
Therapeutic indicationTreatment of mild to moderate type 1 Gaucher disease
More information PDF iconSummary of opinion for Miglustat Gen.Orph

Name of medicineRitonavir Mylan
INNritonavir
Marketing-authorisation applicantMYLAN S.A.S
Therapeutic indicationTreatment of HIV infection
More information PDF iconSummary of opinion for Ritonavir Mylan

Positive recommendations on new biosimilar medicines

Name of medicineCyltezo
INNadalimumab
Marketing-authorisation applicantBoehringer Ingelheim International GmbH
Therapeutic indicationTreatment of rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, paediatric plaque psoriasis, hidradenitis suppurativa, Crohn's disease, ulcerative colitis and uveitis
More information PDF iconSummary of opinion for Cyltezo

Name of medicineOntruzant
INNtrastuzumab
Marketing-authorisation applicantSamsung Bioepis UK Limited (SBUK)
Therapeutic indicationTreatment of early and metastatic breast cancer, and metastatic gastric cancer
More information PDF iconSummary of opinion for Ontruzant

Negative recommendations for new medicines following re-examination

Name of medicineAdlumiz
INNanamorelin hydrochloride
Marketing-authorisation applicantHelsinn Birex Pharmaceuticals Ltd
Therapeutic indicationTreatment of anorexia, cachexia or unintended weight loss in adult patients with non-small cell lung cancer
More information PDF iconQuestions and answers on Adlumiz

Name of medicineHuman IgG1 monoclonal antibody specific for human interleukin-1 alpha XBiotech
INNhuman IgG1 monoclonal antibody specific for human interleukin-1 alpha
Marketing-authorisation applicantXBiotech Germany GmbH
Therapeutic indicationTreatment of debilitating symptoms of advanced colorectal cancer
More informationQuestions and answers on Human IGG1 monoclonal antibody specific for human interleukin-1 alpha XBiotech

Name of medicineMasipro
INNmasitinib
Marketing-authorisation applicantAB Science
Therapeutic indicationTreatment of systemic mastocytosis
More information PDF iconQuestions and answers on Masipro

Positive recommendations on extensions of therapeutic indications

Name of medicineFirazyr
INNicatibant
Marketing-authorisation holderShire Orphan Therapies GmbH
More information PDF iconSummary of opinion for Firazyr

Name of medicineStribild
INNelvitegravir / cobicistat / emtricitabine / tenofovir disoproxil
Marketing-authorisation holderGilead Sciences International Limited
More information PDF iconSummary of opinion for Stribild

Name of medicineTasigna
INNnilotinib
Marketing-authorisation holderNovartis Europharm Ltd
More information PDF iconSummary of opinion for Tasigna

Negative recommendation on extension of therapeutic indication

Name of medicineRaxone
INNidebenone
Marketing-authorisation holderSanthera Pharmaceuticals (Deutschland) GmbH
More information PDF iconQuestions and answers on Raxone

Public health recommendation

Name of medicineFactor VIII
More informationFactor VIII medicines: no clear and consistent evidence of difference in risk of inhibitor development between classes

Withdrawal of applications

Name of medicineFulphila
INNpegfilgrastim
More information PDF iconQuestions and answers on Fulphila

Name of medicineOgivri
INNtrastuzumab
More information PDF iconQuestions and answers on Ogivri

Name of medicineTigecycline Accord
INNtigecycline
More information PDF iconQuestions and answers on Tigecycline Accord

Name of medicineOpdivo
INNnivolumab
More information PDF iconQuestions and answers on Opdivo

Other outcome

Name of medicineBenlysta
INNbelimumab
Marketing-authorisation holderGlaxo Group Ltd
More information PDF iconSummary of opinion for Benlysta

Other updates

PDF iconRecommendations on eligibility to PRIME scheme
PDF iconScientific advice and protocol assistance
PDF iconStart of Community reviews

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