Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 September 2013
News
Human
This page provides an overview of the opinions adopted at the September 2013 meeting of the Committee for Medicinal Products for Human Use (CHMP) and other important outcomes. This month, the Committee recommended 11 new medicines for approval – the most medicines recommended for approval at a CHMP meeting so far in 2013.
Eleven new medicines recommended for approval
The CHMP recommended the approval of two medicines for cancer: Kadcyla for the treatment of metastatic breast cancer and Xofigo for the treatment of castration-resistant prostate cancer.
The Committee also gave positive recommendations for three medicines intended to treat neurological disorders: Abilify Maintena for the treatment of schizophrenia, Memantine Accord, a generic medicine, for the treatment of Alzheimer's disease and Levodopa/Carbidopa/Entacapone Sandoz, which was submitted as a so-called informed consent application, for the treatment of adult patients with Parkinson's disease.
The CHMP also recommended that Vitekta should be granted marketing authorisation for the treatment of human-immunodeficiency-virus?1 (HIV?1) infection in adults who are infected with HIV?1 without known mutations associated with resistance to elvitegravir.
Invokana received a positive opinion for marketing authorisation for the treatment of type-2 diabetes mellitus.
NovoEight was recommended for marketing authorisation for the treatment of haemophilia A and Relvar Ellipta received a positive opinion from the Committee for the treatment of asthma and chronic obstructive pulmonary disorder (COPD).
The vaccine Fluenz Tetra was recommended for a marketing authorisation for the prevention of influenza in children and adolescents 24 months to less than 18 years of age.
The Committee recommended that Lidocaine/Prilocaine Plethora should be granted marketing authorisation for the treatment of primary premature ejaculation in adult men.
Four recommendations on extensions of therapeutic indications
The CHMP recommended an extension to the existing indications for Cimzia, Kineret, Votubia and Yervoy.
Two re-examination procedures for referral opinions started
The CHMP started a re-examination procedure for dihydroergotoxine, one of the medicines included in the Article-31 referral procedure on ergot derivatives. The other ergot derivatives in this referral are not included in this re-examination.
The Committee also started a re-examination procedure for metoclopramide-containing medicines.
More information on these, and all other outcomes of this month's meeting, are available in the table below.
CHMP welcomes new members
At the September CHMP, Daniel Brasseur, former Chair of the Paediatric Committee (PDCO), replaced Pieter Neels as the Belgian CHMP member. Before joining the PDCO, Dr Brasseur was chair of the CHMP. Pieter de Graeff replaced Barbara van Zwieten-Boot as the new CHMP member from the Netherlands, and Greg Markey became the new CHMP member from the United Kingdom, replacing Ian Hudson, who was recently appointed Chief Executive of the United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA).
Positive recommendations on new medicines
| Name of medicine | Abilify Maintena |
|---|---|
| International non-proprietary name (INN) | aripiprazole |
| Marketing-authorisation applicant | Otsuka Pharmaceutical Europe Ltd |
| Therapeutic indication | Treatment of schizophrenia |
| More information | CHMP summary of positive opinion for Abilify Maintena |
| Name of medicine | Fluenz Tetra |
|---|---|
| Common name | influenza vaccine (live attenuated, nasal) |
| Marketing-authorisation applicant | MedImmune LLC |
| Therapeutic indication | Prophylaxis of influenza in children and adolescents 24 months to less than 18 years of age |
| More information | CHMP summary of opinion for Fluenz Tetra |
| Name of medicine | Invokana |
|---|---|
| INN | canagliflozin |
| Marketing-authorisation applicant | Janssen-Cilag International N.V. |
| Therapeutic indication | Treatment of type-2 diabetes mellitus |
| More information | CHMP summary of positive opinion for Invokana |
| Name of medicine | Kadcyla |
|---|---|
| INN | trastuzumab emtansine |
| Marketing-authorisation applicant | Roche Registration Ltd |
| Therapeutic indication | Treatment of metastatic breast cancer |
| More information | CHMP summary of positive opinion for Kadcyla |
| Name of medicine | Lidocaine/Prilocaine Plethora |
|---|---|
| INN | lidocaine / prilocaine |
| Marketing-authorisation applicant | Plethora Solutions Ltd |
| Therapeutic indication | Treatment of primary premature ejaculation in adult men |
| More information | CHMP summary of positive opinion for Lidocaine/Prilocaine Plethora |
| Name of medicine | NovoEight |
|---|---|
| INN | turoctocog alfa |
| Marketing-authorisation applicant | Novo Nordisk A/S |
| Therapeutic indication | Treatment of haemophilia A (congenital factor-VIII deficiency) |
| More information | CHMP summary of positive opinion for NovoEight |
| Name of medicine | Relvar Ellipta |
|---|---|
| INN | fluticasone furoate / vilanterol |
| Marketing-authorisation applicant | Glaxo Group Ltd |
| Therapeutic indication | Treatment of asthma and chronic obstructive pulmonary disorder (COPD) |
| More information | CHMP summary of positive opinion for Relvar Ellipta |
| Name of medicine | Vitekta |
|---|---|
| INN | elvitegravir |
| Marketing-authorisation applicant | Gilead Sciences International Ltd |
| Therapeutic indication | Treatment of human-immunodeficiency-virus?1 (HIV?1) infection in adults who are infected with HIV?1 without known mutations associated with resistance to elvitegravir |
| More information | CHMP summary of positive opinion for Vitekta |
| Name of medicine | Xofigo |
|---|---|
| INN | radium-223 |
| Marketing-authorisation applicant | Bayer Pharma AG |
| Therapeutic indication | Treatment of castration-resistant prostate cancer |
| More information | CHMP summary of positive opinion for Xofigo |
Positive recommendation on new informed-consent application
| Name of medicine | Levodopa/Carbidopa/Entacapone Sandoz |
|---|---|
| INN | levodopa / carbidopa / entacapone |
| Marketing-authorisation applicant | Orion Corporation |
| Therapeutic indication | Treatment of adult patients with Parkinson's disease |
| More information | CHMP summary of positive opinion for Levodopa/Carbidopa/Entacapone Sandoz |
Positive recommendation on new generic medicine
| Name of medicine | Memantine Accord |
|---|---|
| INN | memantine |
| Marketing-authorisation applicant | Accord Healthcare Limited |
| Therapeutic indication | Treatment of Alzheimer's disease |
| More information | CHMP summary of positive opinion for Memantine Accord |
Positive recommendations on extensions of therapeutic indications
| Name of medicine | Cimzia |
|---|---|
| INN | certolizumab pegol |
| Marketing-authorisation holder | UCB Pharma SA |
| More information | CHMP post-authorisation summary of positive opinion for Cimzia |
| Name of medicine | Kineret |
|---|---|
| INN | anakinra |
| Marketing-authorisation holder | Biovitrum AB (publ) |
| More information | CHMP post-authorisation summary of positive opinion for Kineret |
| Name of medicine | Votubia |
|---|---|
| INN | everolimus |
| Marketing-authorisation holder | Novartis Europharm Ltd |
| More information | CHMP post-authorisation summary of positive opinion for Votubia |
| Name of medicine | Yervoy |
|---|---|
| INN | ipilimumab |
| Marketing-authorisation holder | Bristol-Myers Squibb Pharma EEIG |
| More information | CHMP post-authorisation summary of positive opinion for Yervoy |
Recommendations for new contraindications
| Name of medicine | Edarbi |
|---|---|
| INN | azilsartan medoxomil |
| Marketing-authorisation holder | Takeda Global Research and Development Centre (Europe) Ltd |
| More information | CHMP post-authorisation summary of positive opinion for Edarbi |
| Name of medicine | Ipreziv |
|---|---|
| INN | azilsartan medoxomil |
| Marketing-authorisation holder | Takeda Global Research and Development Centre (Europe) Ltd |
| More information | CHMP post-authorisation summary of positive opinion for Ipreziv |
| Name of medicine | Thymanax |
|---|---|
| INN | agomelatine |
| Marketing-authorisation holder | Servier (Ireland) Industries Ltd |
| More information | CHMP post-authorisation summary of positive opinion for Thymanax |
| Name of medicine | Valdoxan |
|---|---|
| INN | agomelatine |
| Marketing-authorisation holder | Les Laboratoires Servier |
| More information | CHMP post-authorisation summary of positive opinion for Valdoxan |
Outcome of arbitration procedure
| Name of medicine | Didanosine |
|---|---|
| INN | didanosine |
| Marketing-authorisation holder | Aurobindo Pharma (Malta) Limited |
| More information | Didanosine |
Re-examinations started
| Name of medicine | Ergot derivatives |
|---|---|
| INN | dihydroergotoxine |
| More information | Ergot derivatives |
| Name of medicine | Metoclopramide-containing medicines |
|---|---|
| INN | metoclopramide |
| More information | Metoclopramide-containing medicines |
Other updates
| Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures adopted at the CHMP meeting of 16-19 September 2013 |
| Opinions on safety variations / periodic safety update reports adopted at the CHMP meeting of 16-19 September 2013 |
| Start of Community reviews - CHMP meeting of 16-19 September 2013 |
| Scientific advice and protocol assistance adopted during the CHMP meeting 16-19 September 2013 |
| Guidelines and concept papers adopted during the CHMP meeting 16-19 September 2013 |
| Overview of invented names reviewed in September 2013 by the Name Review Group (NRG) |
| Organisational matters - CHMP meeting 16-19 September 2013 |
| Opinions on consultation procedures on ancillary medicinal substances in medical devices |