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

Four recommendations on extensions of therapeutic indications

The Committee recommended extensions of indications for Benlysta, 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.

 

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Name of medicine Elebrato Ellipta
International non-proprietary name (INN) fluticasone furoate / umeclidinium / vilanterol
Marketing-authorisation applicant GlaxoSmithKline Trading Services
Therapeutic indication Treatment of adults with moderate to severe chronic obstructive pulmonary disease
More information Summary of opinion for Elebrato Ellipta
Name of medicine Tremfya
INN guselkumab
Marketing-authorisation applicant Janssen-Cilag International N.V.
Therapeutic indication Treatment of plaque psoriasis
More information Summary of opinion for Tremfya
Name of medicine Nyxoid
INN naloxone
Marketing-authorisation applicant Mundipharma Corporation Limited
Therapeutic indication

Treatment of opioid overdose

More information Summary of opinion for Nyxoid
Name of medicine Tookad
INN padeliporfin
Marketing-authorisation applicant STEBA Biotech S.A.
Therapeutic indication

Treatment of adenocarcinoma of the prostate

More information Summary of opinion for Tookad
Name of medicine Trelegy Ellipta
INN fluticasone furoate / umeclidinium / vilanterol
Marketing-authorisation applicant GlaxoSmithKline Trading Services
Therapeutic indication Treatment of adults with moderate to severe chronic obstructive pulmonary disease
More information Summary of opinion for Trelegy Ellipta
Name of medicine VeraSeal
INN human fibrinogen/human thrombin
Marketing-authorisation applicant Instituto Grifols, S.A.
Therapeutic indication Use as a sealant during surgical operations in adults
More information Summary of opinion for VeraSeal
Name of medicine Zejula
INN niraparib
Marketing-authorisation applicant Tesaro UK Limited
Therapeutic indication Treatment of ovarian cancer
More information Summary of opinion for Zejula
Name of medicine Zubsolv
INN buprenorphine / naloxone
Marketing-authorisation applicant Mundipharma Corporation Limited
Therapeutic indication Treatment of opioid dependence
More information Summary of opinion for Zubsolv
Name of medicine Imatinib Teva B.V.
INN imatinib
Marketing-authorisation applicant Teva B.V.
Therapeutic indication

Treatment of leukaemia and gastrointestinal stromal tumours

More information Summary of opinion for Imatinib Teva B.V.
Name of medicine Miglustat Gen.Orph
INN miglustat
Marketing-authorisation applicant Gen.Orph
Therapeutic indication Treatment of mild to moderate type 1 Gaucher disease
More information Summary of opinion for Miglustat Gen.Orph
Name of medicine Ritonavir Mylan
INN ritonavir
Marketing-authorisation applicant MYLAN S.A.S
Therapeutic indication Treatment of HIV infection
More information Summary of opinion for Ritonavir Mylan
Name of medicine Cyltezo
INN adalimumab
Marketing-authorisation applicant Boehringer Ingelheim International GmbH 
Therapeutic indication

Treatment 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 Summary of opinion for Cyltezo
Name of medicine Ontruzant
INN trastuzumab 
Marketing-authorisation applicant Samsung Bioepis UK Limited (SBUK)
Therapeutic indication Treatment of early and metastatic breast cancer, and metastatic gastric cancer
More information Summary of opinion for Ontruzant
Name of medicine Adlumiz
INN anamorelin hydrochloride
Marketing-authorisation applicant Helsinn Birex Pharmaceuticals Ltd 
Therapeutic indication Treatment of anorexia, cachexia or unintended weight loss in adult patients with non-small cell lung cancer 
More information Questions and answers on Adlumiz
Name of medicine Human IgG1 monoclonal antibody specific for human interleukin-1 alpha XBiotech
INN human IgG1 monoclonal antibody specific for human interleukin-1 alpha
Marketing-authorisation applicant XBiotech Germany GmbH 
Therapeutic indication

Treatment of debilitating symptoms of advanced colorectal cancer

More information Questions and answers on Human IGG1 monoclonal antibody specific for human interleukin-1 alpha XBiotech
Name of medicine Masipro
INN masitinib 
Marketing-authorisation applicant AB Science 
Therapeutic indication

Treatment of systemic mastocytosis

More information Questions and answers on Masipro
Name of medicine Benlysta
INN belimumab 
Marketing-authorisation holder Glaxo Group Ltd
More information Summary of opinion for Benlysta
Name of medicine Tasigna
INN nilotinib 
Marketing-authorisation holder Novartis Europharm Ltd
More information Summary of opinion for Tasigna
Name of medicine Firazyr
INN icatibant 
Marketing-authorisation holder Shire Orphan Therapies GmbH
More information Summary of opinion for Firazyr
Name of medicine Stribild
INN elvitegravir / cobicistat / emtricitabine / tenofovir disoproxil 
Marketing-authorisation holder Gilead Sciences International Limited
More information Summary of opinion for Stribild
Name of medicine Raxone
INN idebenone 
Marketing-authorisation holder Santhera Pharmaceuticals (Deutschland) GmbH 
More information Questions and answers on Raxone
Name of medicine Factor VIII
More information Factor VIII medicines: no clear and consistent evidence of difference in risk of inhibitor development between classes
Name of medicine Fulphila
INN pegfilgrastim 
More information Questions and answers on Fulphila
Name of medicine Ogivri
INN trastuzumab 
More information Questions and answers on Ogivri
Name of medicine Tigecycline Accord
INN tigecycline 
More information Questions and answers on Tigecycline Accord
Name of medicine Opdivo
INN nivolumab
More information Questions and answers on Opdivo
Recommendations on eligibility to PRIME scheme
Scientific advice and protocol assistance
Start of Community reviews

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