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