Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 February 2016

News 26/02/2016

Six medicines, including two orphan medicines, recommended for approval

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended six new medicines for marketing authorisation at its February 2016 meeting.

The CHMP recommended granting marketing authorisations for two medicines for the prevention and treatment of bleeding in patients with haemophilia B, Alprolix (eftrenonacog alfa) and Idelvion (albutrepenonacog alfa). Both these medicines have an orphan designation.

Lonsurf (trifluridine / tipiracil) was recommended by the CHMP for the treatment of metastatic colorectal cancer.

Descovy (emtricitabine / tenofovir alafenamide) received a positive opinion for the treatment of HIV infection.

The CHMP recommended granting a marketing authorisation for Taltz (ixekizumab) for the treatment of plaque psoriasis.

The generic medicine Palonosetron Hospira (palonosetron) received a positive recommendation from the Committee for the prevention of nausea and vomiting associated with chemotherapy.

Seven recommendations on extensions of therapeutic indications

The Committee recommended extensions of indications for Giotrif, Humira, Ruconest, TachoSil, Zydelig and two extensions of indications for Opdivo. For more information on the extensions of indications for Opdivo, please see the press release in the grid below.

Start of review: medicines containing dienogest and ethinylestradiol

The CHMP started a review of medicines containing dienogest 2 mg and ethinylestradiol 0.03 mg when used for acne. These products are available in several countries in the European Union (EU) as oral contraceptives and for the treatment of moderate acne in women. For more information, please refer to the start of referral document in the grid below.

Outcome of review on SGLT2 inhibitors: recommendations to minimise risk of diabetic ketoacidosis

The CHMP confirmed recommendations from the Pharmacovigilance Risk Assessment Committee (PRAC) to minimise the risk of diabetic ketoacidosis in patients taking SGLT2 inhibitors (a class of type 2 diabetes medicines). For more information, please see the public health communication in the grid below.

CHMP confirms recommendations to minimise risk of the brain infection PML with Tysabri

EMA's scientific review of the known risk of progressive multifocal leukoencephalopathy (PML) with the multiple sclerosis medicine Tysabri (natalizumab) is now completed, with the CHMP confirming the PRAC recommendations aimed at minimising this risk. For more information, please see the public health communication in the grid below.

PRIME and early access tools

The CHMP adopted the final document on PRIME, a new scheme to support the development of medicines addressing unmet medical needs, as well as revised guidelines on the implementation of accelerated assessment and conditional marketing authorisation. These documents will be published on the EMA website in early March.

Agenda and minutes

The agenda of the February 2016 meeting is published on EMA's website. Minutes of the January 2016 CHMP meeting will be published next week.

CHMP statistics

Key figures from the February 2016 CHMP meeting are represented in the graphic below.

More information on this, and all other outcomes of the CHMP's February 2016 meeting, is available in the grid below.

 February 2016

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Positive recommendations on new medicines

Name of medicineAlprolix
INNeftrenonacog alfa
Marketing-authorisation applicantBiogen Idec Ltd
Therapeutic indicationTreatment and prophylaxis of bleeding in patients with haemophilia B
More information PDF iconSummary of opinion for Alprolix

Name of medicineDescovy
INNemtricitabine / tenofovir alafenamide
Marketing-authorisation applicantGilead Sciences International Ltd
Therapeutic indicationTreatment of HIV infection
More information PDF iconSummary of opinion for Descovy

Name of medicineIdelvion
INNalbutrepenonacog alfa
Marketing-authorisation applicantCSL Behring GmbH
Therapeutic indicationTreatment and prophylaxis of bleeding in patients with haemophilia B
More information PDF iconSummary of opinion for Idelvion

Name of medicineLonsurf
INNtrifluridine / tipiracil
Marketing-authorisation applicantLes Laboratoires Servier
Therapeutic indicationTreatment of metastatic colorectal cancer
More information PDF iconSummary of opinion for Lonsurf

Name of medicineTaltz
INNixekizumab
Marketing-authorisation applicantEli Lilly Nederland B.V.
Therapeutic indicationTreatment of plaque psoriasis
More information PDF iconSummary of opinion for Taltz

Positive recommendation on new generic medicine

Name of medicinePalonosetron Hospira
INNpalonosetron
Marketing-authorisation applicantHospira UK Limited
Therapeutic indicationPrevention of nausea and vomiting associated with cancer chemotherapy
More information PDF iconSummary of opinion for Palonosetron Hospira

Positive recommendations on extensions of therapeutic indications

Name of medicineGiotrif
INNafatinib
Marketing-authorisation holderBoehringer Ingelheim International GmbH
More information PDF iconSummary of opinion for Giotrif

Name of medicineHumira
INNadalimumab
Marketing-authorisation holderAbbVie Ltd
More information PDF iconSummary of opinion for Humira

Name of medicineOpdivo
INNnivolumab
Marketing-authorisation holderBristol-Myers Squibb Pharma EEIG
More information

PDF iconSummary of opinion for Opdivo

Press release: New treatment for advanced form of kidney cancer

Name of medicineRuconest
INNconestat alfa
Marketing-authorisation holderPharming Group N.V
More information PDF iconSummary of opinion for Ruconest

Name of medicineTachoSil
INNhuman thrombin / human fibrinogen
Marketing-authorisation holderTakeda Austria GmbH
More information PDF iconSummary of opinion for TachoSil

Name of medicineZydelig
INNidelalisib
Marketing-authorisation holderGilead Sciences International Ltd
More information PDF iconSummary of opinion for Zydelig

Recommendation for new contraindication

Name of medicineTelzir
INNfosamprenavir
Marketing-authorisation holderViiV Healthcare UK Limited
More information PDF iconSummary of opinion for Telzir

Start of referral

Name of medicineDienogest / Ethinylestradiol containing medicinal products indicated in acne
INNdienogest / ethinylestradiol
More informationStart of review of medicines containing dienogest 2 mg and ethinylestradiol 0.03 mg for acne

Public health recommendations

Name of medicineTysabri
INNnatalizumab
Marketing-authorisation holderBiogen Idec Ltd
More informationEMA confirms recommendations to minimise risk of brain infection PML with Tysabri

Name of medicineSGLT2 inhibitors
INNcanagliflozin, dapagliflozin, empagliflozin
Marketing-authorisation holderAstraZeneca AB (Forxiga, Xigduo), Boehringer Ingelheim International GmbH (Jardiance, Synjardy), Janssen-Cilag International N.V. (Invokana, Vokanamet)
More informationEMA confirms recommendations to minimise ketoacidosis risk with SGLT2 inhibitors for diabetes

Outcome of harmonisation procedure

Name of medicine Cymevene
INNganciclovir
Marketing-authorisation holderF. Hoffmann-La Roche
More informationQuestions and answers on Cymevene and associated names (ganciclovir, 500 mg powder for concentrate for solution for infusion, intravenous

Other updates

PDF iconOpinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures
PDF iconOpinions on safety variations
PDF iconStart of Community reviews
PDF iconScientific advice and protocol assistance
PDF iconGuidelines and concept papers adopted
PDF iconOverview of invented names reviewed in February 2016 by the Name Review Group (NRG)
PDF iconOrganisational matters

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