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

24 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 statistics: February 2017

CHMP statistics: February 2017

Positive recommendations on new medicines

Name of medicine	Lokelma
INN	sodium zirconium cyclosilicate
Marketing-authorisation applicant	AstraZeneca AB
Therapeutic indication	Treatment of hyperkalaemia
More information	CHMP summary of positive opinion for Lokelma

 

Name of medicine	Natpar
INN	parathyroid hormone
Marketing-authorisation applicant	Shire Pharmaceuticals Ireland Ltd
Therapeutic indication	Treatment of hypoparathyroidism
More information	CHMP summary of positive opinion for Natpar   Press release: First hormone replacement therapy for hypoparathyroidism

 

Name of medicine	Varuby
INN	rolapitant
Marketing-authorisation holder	Tesaro UK Limited
Therapeutic indication	Prevention of nausea and vomiting
More information	CHMP summary of positive opinion for Varuby

 

Positive recommendation on new informed-consent application

Name of medicine	Roteas
INN	edoxaban
Marketing-authorisation applicant	Daiichi Sankyo Europe GmbH
Therapeutic indication	Prevention of stroke and systemic embolism in adults with atrial fibrillation, and for the treatment and prevention of deep vein thrombosis and pulmonary embolism
More information	CHMP summary of positive opinion for Roteas

 

Positive recommendations on new generic medicines

Name of medicine	Emtricitabine/tenofovir disoproxil Krka d.d.
INN	emtricitabine / tenofovir disoproxil
Marketing-authorisation applicant	KRKA, d.d., Novo mesto
Therapeutic indication	Treatment of HIV
More information	CHMP summary of positive opinion for Emtricitabine/Tenofovir disoproxil Krka d.d.

 

Name of medicine	Pemetrexed Hospira UK Limited
INN	pemetrexed
Marketing-authorisation holder	Hospira UK Limited
Therapeutic indication	Treatment of unresectable malignant pleural mesothelioma and locally advanced or metastatic non-small cell lung cancer
More information	CHMP summary of positive opinion for Pemetrexed Hospira UK Limited

 

Positive recommendations on extensions of therapeutic indications

Name of medicine	Darzalex
INN	daratumumab
Marketing-authorisation holder	Janssen-Cilag International NV
More information	CHMP post-authorisation summary of positive opinion for Darzalex

 

Name of medicine	Mekinist
INN	trametinib dabrafenib
Marketing-authorisation holder	Novartis Europharm Ltd
More information	CHMP post-authorisation summary of positive opinion for Mekinist

 

Name of medicine	Tafinlar
INN	trametinib dabrafenib
Marketing-authorisation holder	Novartis Europharm Ltd
More information	CHMP post-authorisation summary of positive opinion for Tafinlar

 

Name of medicine	Truvada
INN	emtricitabine / tenofovir disoproxil
Marketing-authorisation holder	Gilead Sciences International Ltd
More information	CHMP post-authorisation summary of positive opinion for Truvada

 

Public health recommendation

Name of medicine	Sodium-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 medicine	Haldol and associated names
INN	haloperidol
Marketing-authorisation holder	Janssen-Cilag Group of companies and associated companies
More information	Questions and answers on Haldol and associated names

 

Name of medicine	Haldol decanoate and associated name
INN	haloperidol
Marketing-authorisation holder	Janssen-Cilag Group of companies and associated companies
More information	Questions and answers on Haldol decanoate and associated name

 

Name of medicine	Saroten and associated names
INN	amitriptyline
Marketing-authorisation holder	H. Lundbeck A/S group of companies and associated companies, Bayer Vital GmBH and PNG Gerolymatos Medical A.E.
More information	Questions and answers on Saroten and associated names

 

Other updates

Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 20-23 February 2017

Scientific advice and protocol assistance adopted during the CHMP meeting 20 – 23 February 2017

Overview of (invented) names reviewed in February 2017 by the Name Review Group (NRG) adopted at the CHMP meeting of 20-23 February 2017

Start of community reviews - CHMP meeting of 20-23 February 2017