Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 February 2017

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24/02/2017

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 February 2017

Six medicines recommended for approval, including one orphan

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended six medicines for approval at its February meeting.

The CHMP recommended granting a conditional marketing authorisation for Natpar (parathyroid hormone) as a treatment for patients with chronic hypoparathyroidism who cannot be adequately controlled with standard treatment with calcium and vitamin D. Natpar has an orphan designation. For more information, please see the press release in the grid below.

The Committee recommended granting a marketing authorisation for Lokelma (sodium zirconium cyclosilicate) for the treatment of hyperkalaemia.

Varuby (rolapitant) was recommended for approval by the Committee for the prevention of nausea and vomiting.

The CHMP granted a positive opinion for one informed consent application: Roteas (edoxaban) for the prevention of stroke and systemic embolism in adults with atrial fibrillation, and for the treatment and prevention of deep vein thrombosis and pulmonary embolism. An informed consent application makes use of data from the dossier of a previously authorised medicine, with the marketing authorisation holder of that medicine giving consent for the use of their data in the application.

Two generic medicines received a positive opinion from the Committee: Emtricitabine / Tenofovir disoproxil Krka d.d. (emtricitabine / tenofovir disoproxil) for the treatment of HIV infection and Pemetrexed Hospira UK Limited (pemetrexed) for the treatment of unresectable malignant pleural mesothelioma and locally advanced or metastatic non-small cell lung cancer.

Four recommendations on extensions of therapeutic indications

The Committee recommended extensions of indications for Darzalex, Mekinist, Tafinlar and Truvada.

Outcome of review on SGLT2 inhibitors

The CHMP is informing patients and healthcare professionals of a potential increased risk of lower limb amputation (mostly affecting the toes) in patients taking the SGLT2 inhibitors canagliflozin, dapagliflozin and empagliflozin used for type 2 diabetes. Patients taking these medicines are reminded to check their feet regularly and follow their doctor’s advice on routine preventative foot care. They should also tell their doctor if they notice any wounds or discoloration, or if their feet are tender or painful. For more information please see the public health communication in the grid below.

Agenda and minutes

The agenda of the February 2017 meeting is published on EMA’s website. Minutes of the January 2017 CHMP meeting will be published next week.

CHMP statistics

Key figures from the February 2017 CHMP meeting are represented in the graphic below.

More information on this, and all other outcomes of the CHMP’s February 2017 meeting, is available in the grid below.

 CHMP_highlights_February_2017

Download image in pdf format

Positive recommendations on new medicines

Name of medicineLokelma
INNsodium zirconium cyclosilicate
Marketing-authorisation applicantAstraZeneca AB
Therapeutic indicationTreatment of hyperkalaemia
More informationSummary of opinion for Lokelma

 

Name of medicineNatpar
INNparathyroid hormone
Marketing-authorisation applicantShire Pharmaceuticals Ireland Ltd
Therapeutic indicationTreatment of hypoparathyroidism
More information

Summary of opinion for Natpar


Press release: First hormone replacement therapy for hypoparathyroidism

 

Name of medicineVaruby
INNrolapitant
Marketing-authorisation holderTesaro UK Limited
Therapeutic indicationPrevention of nausea and vomiting
More informationSummary of opinion for Varuby

 

Positive recommendation on new informed-consent application

Name of medicineRoteas
INNedoxaban
Marketing-authorisation applicantDaiichi Sankyo Europe GmbH
Therapeutic indicationPrevention of stroke and systemic embolism in adults with atrial fibrillation, and for the treatment and prevention of deep vein thrombosis and pulmonary embolism
More informationSummary of opinion for Roteas

 

Positive recommendations on new generic medicines

Name of medicineEmtricitabine/tenofovir disoproxil Krka d.d.
INNemtricitabine / tenofovir disoproxil
Marketing-authorisation applicantKRKA, d.d., Novo mesto
Therapeutic indicationTreatment of HIV
More informationSummary of opinion for Emtricitabine/tenofovir disoproxil Krka d.d.

 

Name of medicinePemetrexed Hospira UK Limited
INNpemetrexed
Marketing-authorisation holderHospira UK Limited
Therapeutic indication

Treatment of unresectable malignant pleural mesothelioma and locally advanced or metastatic non-small cell lung cancer

More informationSummary of opinion for Pemetrexed Hospira UK Limited

 

Positive recommendations on extensions of therapeutic indications

Name of medicineDarzalex
INNdaratumumab
Marketing-authorisation holderJanssen-Cilag International NV
More informationSummary of opinion for Darzalex

   

Name of medicineMekinist
INNtrametinib dabrafenib
Marketing-authorisation holderNovartis Europharm Ltd
More informationSummary of opinion for Mekinist

   

Name of medicineTafinlar
INNtrametinib dabrafenib
Marketing-authorisation holderNovartis Europharm Ltd
More informationSummary of opinion for Tafinlar

            

Name of medicineTruvada
INNemtricitabine / tenofovir disoproxil
Marketing-authorisation holderGilead Sciences International Ltd
More informationSummary of opinion for Truvada

 

Public health recommendation

Name of medicineSodium-glucose co-transporter 2 (SGLT2) inhibitors
More information SGLT2 inhibitors: information on potential risk of toe amputation to be included in prescribing information

 

Outcome of harmonisation procedure

Name of medicineHaldol and associated names
INNhaloperidol
Marketing-authorisation holderJanssen-Cilag Group of companies and associated companies
More informationQuestions and answers on Haldol and associated names

 

Name of medicineHaldol decanoate and associated name
INNhaloperidol
Marketing-authorisation holderJanssen-Cilag Group of companies and associated companies
More informationQuestions and answers on Haldol decanoate and associated name

 

Name of medicineSaroten and associated names
INNamitriptyline
Marketing-authorisation holderH. Lundbeck A/S group of companies and associated companies, Bayer Vital GmBH and PNG Gerolymatos Medical A.E.
More informationQuestions and answers on Saroten and associated names

 

Other updates

Recommendations on eligibility to PRIME scheme
Scientific advice and protocol assistance
Overview of (invented) names reviewed in February 2017 by the Name Review Group (NRG)
Start of community reviews

 

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