Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 March 2018

News 23/03/2018

Six medicines recommended for approval, including one orphan

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended six medicines for approval, including one orphan medicine1, at its March 2018 meeting.

The CHMP recommended granting a conditional marketing authorisation for Rubraca (rucaparib), for the treatment of relapsed or progressive ovarian cancer. Rubraca was designated as an orphan medicine during its development.

Juluca (dolutegravir / rilpivirine) received a positive opinion for the treatment of human immunodeficiency virus (HIV) infection.

Two biosimilar medicines were recommended for approval by the Committee: Kanjinti (trastuzumab) for the treatment of breast and gastric cancer; and Zessly (infliximab) for the treatment of rheumatoid arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis.

Two generic medicines received a positive opinion from the CHMP: Pemetrexed Krka (pemetrexed), for the treatment of malignant pleural mesothelioma and non-small cell lung cancer; and Prasugrel Mylan (prasugrel), for the prevention of atherothrombotic events.

Negative opinions on two new medicines

The CHMP adopted a negative opinion for Dexxience (betrixaban). Dexxience was expected to be used for the prevention of venous thromboembolism.

The Committee also adopted a negative opinion for Eladynos (abaloparatide). Eladynos was intended to be used to treat osteoporosis.

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

Negative recommendation on new medicine following re-examination

The CHMP confirmed its previous recommendation to refuse the granting of a marketing authorisation for Aplidin (plitidepsin). Aplidin was expected to be used to treat adults with multiple myeloma. This followed a request from the applicant for the re-examination of the Committee's negative opinion for the medicine adopted at the December 2017 meeting.

For more information on this negative opinion, please see the question-and-answer document in the grid below.

Start of re-examination of recommendation on new medicine

The applicant for Nerlynx (neratinib) has requested a re-examination of the Committee's negative opinion for this medicine adopted at the February 2018 meeting. The CHMP will now re-examine the opinion and issue a final recommendation.

For more information on this negative opinion, please see the question-and-answer document in the grid below.

Three recommendations on extensions of therapeutic indication

The Committee recommended extensions of indications for Cabometyx, Ivemend and Repatha.

Start of re-examination of recommendation on extension of therapeutic indication

The applicant for Sutent (sunitinib) has requested a re-examination of the Committee's negative opinion for this medicine adopted at the February 2018 meeting. The CHMP will now re-examine the opinion and issue a final recommendation.

For more information on this negative opinion, please see the question-and-answer document in the grid below.

Start of referral: omega-3 fatty acid medicines

The CHMP started a review of the use of omega-3 fatty acid medicines in patients who have had a heart attack, following research showing that these oral products may not prevent recurrence of heart disease or stroke. For more information, please see the start-of-referral document in the grid below.

Outcome of review on retinoid medicines

The CHMP concluded its review of retinoid medicines, and confirmed that retinoids can harm the unborn child and must not be used during pregnancy. In addition, a warning on the possibility that neuropsychiatric disorders (such as depression, anxiety and mood changes) may occur will be included in the prescribing information for oral retinoids. For more information, please see the public health recommendation in the grid below.

Withdrawal of application

An application to extend the indication of Aranesp (darbepoetin alfa) to treat anaemia in patients with myelodysplastic syndromes has been withdrawn. A question-and-answer document on this withdrawal is available in the grid below.

Agenda and minutes

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

CHMP statistics

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

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


1As always at time of approval, this orphan designation will now be reviewed by EMA's Committee for Orphan Medicinal Products (COMP) to determine whether the information available to date allows maintaining the medicine's orphan status and granting the medicine ten years of market exclusivity.

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Positive recommendations on new medicines

Name of medicineJuluca
International non-proprietary name (INN)dolutegravir / rilpivirine
Marketing-authorisation applicantViiV Healthcare UK Limited
Therapeutic indicationTreatment of HIV infection
More information PDF iconSummary of opinion for Juluca

Name of medicineRubraca
INNrucaparib
Marketing-authorisation applicantClovis Oncology UK Ltd
Therapeutic indicationTreatment of relapsed or progressive ovarian cancer
More information PDF iconSummary of opinion for Rubraca

Positive recommendations on new generic medicines

Name of medicinePemetrexed Krka
INNpemetrexed
Marketing-authorisation applicantKrka d.d.
Therapeutic indicationTreatment of malignant pleural mesothelioma and non-small cell lung cancer
More information PDF iconSummary of opinion for Pemetrexed Krka

Name of medicinePrasugrel Mylan
INNprasugrel
Marketing-authorisation applicantMylan S.A.S
Therapeutic indicationPrevention of atherothrombotic events
More information PDF iconSummary of opinion for Prasugrel Mylan

Positive recommendations on new biosimilar medicines

Name of medicineKanjinti
INNtrastuzumab
Marketing-authorisation applicantAmgen Europe B.V., BREDA
Therapeutic indicationTreatment of breast and gastric cancer
More information PDF iconSummary of opinion for Kanjinti

Name of medicineZessly
INNinfliximab
Marketing-authorisation applicantSandoz GmbH
Therapeutic indicationTreatment of rheumatoid arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis
More information PDF iconSummary of opinion for Zessly

Negative recommendations for new medicines

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

Negative recommendation for new medicine following re-examination

Name of medicineAplidin
INNplitidepsin
Marketing-authorisation applicantPharma Mar
Therapeutic indicationTreatment of multiple myeloma
More information PDF iconQuestions and answers on Aplidin

Start of re-examination of recommendation for new medicine

Name of medicineNerlynx
INNneratinib
Marketing-authorisation applicantPuma Biotechnology Limited
Therapeutic indicationTreatment of breast cancer
More information PDF iconQuestions and answers on Nerlynx

Positive recommendations on extensions of indications

Name of medicineCabometyx
INNcabozantinib
Marketing-authorisation holderIpsen Pharma
More information PDF iconSummary of opinion for Cabometyx

Name of medicineIvemend
INNfosaprepitant
Marketing-authorisation holderMerck Sharp & Dohme Limited
More information PDF iconSummary of opinion for Ivemend

Name of medicineRepatha
INNevolocumab
Marketing-authorisation holderAmgen Europe B.V.
More information PDF iconSummary of opinion for Repatha

Start of re-examination of recommendation on extension of indication

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

Start of referral

Name of medicineOmega-3 fatty acid medicines
More informationEMA reviewing use of omega-3 fatty acid medicines after heart attacks

Public health recommendation

Name of medicineRetinoid medicines
More informationUpdated measures for pregnancy prevention during retinoid use

Medication error

Name of medicineFiasp
INNinsulin aspart
Marketing-authorisation holderNovo Nordisk A/S
More informationColour change for insulin injection Fiasp to avoid mix ups with Tresiba

Withdrawal of application for extension of indication

Name of medicineAranesp
INNdarbepoetin alfa
Marketing-authorisation applicantAmgen Europe B.V.
More information PDF iconQuestions and answers on Aranesp

Other updates

PDF iconRecommendations on eligibility to PRIME scheme
PDF iconScientific advice and protocol assistance
PDF iconOverview of (invented) names reviewed in February 2018 by the Name Review Group (NRG)

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