Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 28-31 May 2018

News 01/06/2018

Nine medicines recommended for approval, including two orphans

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

The CHMP recommended granting a marketing authorisation for Aimovig (erenumab), the first human monoclonal antibody therapy for prevention of migraine. Aimovig belongs to a new class of medicines that work by blocking the activity of calcitonin gene-related peptide, a molecule that is involved in migraine attacks. For more information, please see the press release in the grid below.

The Committee recommended granting a marketing authorisation for Tegsedi (inotersen), a medicine for patients with hereditary transthyretin amyloidosis that aims to affect the course of the disease and improve quality of life. This medicine was reviewed under EMA's accelerated assessment mechanism, reserved for medicines of major public health interest. Tegsedi was designated as an orphan medicine during its development. For more information, please see the press release in the grid below.

Myalepta (metreleptin) received a positive opinion for the treatment of leptin deficiency. Myalepta was designated as an orphan medicine during its development.

The CHMP recommended granting a marketing authorisation for Rxulti (brexpiprazole), for the treatment of schizophrenia.

Four biosimilar medicines received a positive opinion from the Committee: Halimatoz, Hefiya and Hyrimoz, all containing adalimumab, were recommended for the treatment of certain inflammatory and autoimmune disorders; and Trazimera (trastuzumab), was recommended for the treatment of breast and gastric cancer.

The Committee recommended for approval the generic medicine Nityr (nitisinone), for the treatment of hereditary tyrosinemia type 1.

Negative opinion on new medicine

The CHMP adopted a negative opinion refusing a marketing authorisation for Exondys (eteplirsen). Exondys was expected to be used to treat Duchenne muscular dystrophy. The applicant requested a re-examination of this negative opinion on 1 June 2018. For more information please see the question-and-answer document in the grid below.

Update on re-examination

The applicant for Alsitek (masitinib) has withdrawn the request for re-examination of the Committee's negative opinion for this medicine. For more information please see the question-and-answer document.

Three recommendations on extensions of therapeutic indication

The Committee recommended extensions of indications for Briviact, Translarna and Xeljanz.

Start of referral: metamizole-containing medicines

The Committee also started a review of medicines containing the painkiller metamizole. There are substantial differences between member states in the recommended maximum daily doses of the medicine and the contraindications on its use during pregnancy or in women who are breast feeding. For more information please see the start-of-referral document in the grid below.

Outcome of review on Esmya

The CHMP recommended several measures to minimise the risk of rare but serious liver injury with Esmya (ulipristal acetate), for the treatment of moderate to severe symptoms of uterine fibroids. For more information please see the public health recommendation in the grid below.

Outcome of review on Keytruda and Tecentriq

The CHMP recommended restricting the use of Keytruda (pembrolizumab) and Tecentriq (atezolizumab) as first line-treatments for urothelial cancer, because new data indicate that these medicines may not work as well as chemotherapy in some patients with low levels of the protein PD-L1. For more information please see the public health recommendation in the grid below.

Withdrawal of application

The application for an initial marketing authorisation for Restaysis (ciclosporin) was withdrawn. This medicine was intended to be used for the treatment of moderate dry eye disease. A question-and-answer document on this withdrawal is available in the grid below.

Agenda and minutes

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

CHMP statistics

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

More information on all other outcomes of the CHMP May 2018 meeting is available in the grid 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.

 May 2018

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Positive recommendations on new medicines

Name of medicineAimovig
International non-proprietary name (INN)erenumab
Marketing-authorisation applicantNovartis Europharm Limited
Therapeutic indicationProphylaxis of migraine
More information

PDF iconSummary of opinion for Aimovig

Press release: First monoclonal antibody therapy for prevention of migraine

Name of medicineMyalepta
INNmetreleptin
Marketing-authorisation applicantAegerion Pharmaceuticals B.V.
Therapeutic indicationTreatment of leptin deficiency (lipodystrophy)
More information PDF iconSummary of opinion for Myalepta

Name of medicineRxulti
INNbrexpiprazole
Marketing-authorisation applicantOtsuka Pharmaceutical Europe Ltd
Therapeutic indicationTreatment of schizophrenia
More information PDF iconSummary of opinion for Rxulti

Name of medicineTegsedi
INNinotersen
Marketing-authorisation applicantIONIS USA Ltd
Therapeutic indicationTreatment of hereditary transthyretin amyloidosis
More information

PDF iconSummary of opinion for Tegsedi

Press release: New medicine for hereditary rare disease

Positive recommendations on new generic medicine

Name of medicineNityr
International non-proprietary name (INN)nitisinone
Marketing-authorisation applicantCycle Pharmaceuticals Ltd
Therapeutic indicationTreatment of hereditary tyrosinemia type 1
More information PDF iconSummary of opinion for Nityr

Positive recommendations on new biosimilar medicines

Name of medicineHalimatoz
International non-proprietary name (INN)adalimumab
Marketing-authorisation applicantSandoz GmbH
Therapeutic indicationTreatment of certain inflammatory and autoimmune disorders
More information PDF iconSummary of opinion for Halimatoz

Name of medicineHefiya
INNadalimumab
Marketing-authorisation applicantSandoz GmbH
Therapeutic indicationTreatment of certain inflammatory and autoimmune disorders
More information PDF iconSummary of opinion for Hefiya

Name of medicineHyrimoz
INNadalimumab
Marketing-authorisation applicantSandoz GmbH
Therapeutic indicationTreatment of certain inflammatory and autoimmune disorders
More information PDF iconSummary of opinion for Hyrimoz

Name of medicineTrazimera
INNtrastuzumab
Marketing-authorisation applicantPfizer Europe MA EEIG
Therapeutic indicationTreatment of breast and gastric cancer
More information PDF iconSummary of opinion for Trazimera

Negative recommendation on new medicine

Name of medicineExondys
INNeteplirsen
Marketing-authorisation applicantAVI Biopharma International Ltd
Therapeutic indicationTreatment of Duchenne muscular dystrophy
More information PDF iconQuestions and answers on Exondys

Positive recommendations on extensions of indications

Name of medicineBriviact
INNbrivaracetam
Marketing-authorisation holderUCB Pharma S.A.
More information PDF iconSummary of opinion for Briviact

Name of medicineTranslarna
INNataluren
Marketing-authorisation holderPTC Therapeutics International Limited
More information PDF iconSummary of opinion for Translarna

Name of medicineXeljanz
INNtofacitinib
Marketing-authorisation holderPfizer Limited
More information PDF iconSummary of opinion for Xeljanz

Start of referral

Name of medicineMetamizole containing medicinal products
INNmetamizole sodium
More informationEMA begins review of medicines containing metamizole

Public health recommendations

Name of medicineEsmya
INNulipristal acetate
Marketing-authorisation holderGedeon Richter Plc
More informationEsmya: new measures to minimise risk of rare but serious liver injury

Name of medicineKeytruda and Tecentriq
More informationEMA restricts use of Keytruda and Tecentriq in bladder cancer

Outcome of harmonisation procedure

Name of medicineScandonest and associated names
INNmepivacaine
Marketing-authorisation holderSeptodont group of companies and associated companies
More informationQuestions and answers on Scandonest and associated names

Withdrawal of initial marketing authorisation application

Name of medicineRestaysis
INNciclosporin
Marketing-authorisation applicantAllergan Pharmaceuticals International Limited
More informationQuestions and answers on Restaysis

Other updates

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

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