Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 November 2013
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Human
This page provides an overview of the opinions adopted at the November 2013 meeting of the Committee for Medicinal Products for Human Use (CHMP) and other important outcomes.
Seven medicines recommended for approval
The CHMP recommended granting a marketing authorisation for Sovaldi (sofosbuvir) in combination with other medicines for the treatment of chronic (long-term) hepatitis C in adults. Please see press release for more information.
The CHMP recommended the approval of Tivicay in combination with other anti-retroviral medicines for the treatment of adults and adolescents over 12 years of age infected with human immunodeficiency virus (HIV). Please see press release for more information.
The CHMP recommended marketing authorisations for two tuberculosis medicines. One is Deltyba (delamanid), which is recommended for the treatment of pulmonary infections due to multidrug-resistant tuberculosis; the other is Para-aminosalicylic acid Lucane, recommended for the treatment of multidrug-resistant tuberculosis. Both are orphan medicines. Please see press release for more information.
The Committee also recommended the granting of a marketing authorisation for Xigduo for the treatment of type 2 diabetes.
The Committee gave a positive recommendation for Cholic Acid FGK for the treatment of inborn errors of primary bile acid synthesis. Cholic Acid FGK is an orphan medicine.
The generic medicine Zoledronic Acid Accord also received a positive opinion for use in the prevention of skeletal-related events and treatment of tumour-induced hypercalcaemia.
Update of previous Tecfidera opinion
The CHMP has updated its previous opinion and agreed that dimethyl fumarate in Tecfidera is qualified as a new active substance.
Negative opinion for Masican
The Committee adopted a negative opinion for the orphan medicine Masican, which was intended for the treatment of gastrointestinal stromal tumour.
Three recommendations on extensions of therapeutic indications
The CHMP recommended adding the treatment of patients with metastatic pancreatic cancer to the approved indications for Abraxane. Please see press release for more details.
The Committee also recommended extensions of indications for Pradaxa and Velcade.
New compassionate-use programme
The CHMP has given an opinion on the use of daclatasvir in combination with sofosbuvir in the treatment of chronic (long-term) hepatitis C virus infection, in a compassionate-use programme. More information is available in a separate press release.
Outcome of combined hormonal contraceptives safety review
The CHMP has completed its review of combined hormonal contraceptives (CHCs). The CHMP endorsed the October 2013 recommendation of the Pharmacovigilance Risk Assessment Committee (PRAC) that the benefits of CHCs in preventing unwanted pregnancies continue to outweigh their risks, and that the well-known risk of VTE with all CHCs is small. The review reinforced the importance of ensuring that clear and up-to-date information is provided to women who use these medicines and to the healthcare professionals giving advice and clinical care.
Outcome of safety review of thiocolchicoside-containing medicines
In addition to the safety review on CHCs, the Committee also issued recommendations on thiocolchicoside-containing medicines.
Update on Iclusig
The CHMP made a number of recommendations intended to minimise the risk of blood clots obstructing the arteries and veins in patients taking the leukaemia medicine Iclusig. The recommendations follow a review of data from two ongoing clinical trials indicating that blood clots were occurring at a higher rate than was observed at the time of the medicine's initial authorisation.
More information on these and all other outcomes of this month's meeting are available in the table below.
Positive recommendations on new medicines
| Name of medicine | Cholic Acid FGK |
|---|---|
| International non-proprietary name (INN) | cholic acid |
| Marketing-authorisation applicant | FGK Representative Service GmbH |
| Therapeutic indication | Treatment of inborn errors of primary bile acid synthesis |
| More information | CHMP summary of opinion for Kolbam |
| Name of medicine | Para-aminosalicylic acid Lucane |
|---|---|
| INN | para-aminosalicylic acid |
| Marketing-authorisation applicant | Lucane Pharma SA |
| Therapeutic indication | Treatment of tuberculosis |
| More information |
CHMP summary of positive opinion for Para-aminosalicylic acid Lucane
Press release: European Medicines Agency recommends two new treatment options for tuberculosis |
| Name of medicine | Sovaldi |
|---|---|
| INN | sofosbuvir |
| Marketing-authorisation applicant | Gilead Sciences International Ltd |
| Therapeutic indication | Treatment of chronic hepatitis C |
| More information |
CHMP summary of positive opinion for Sovaldi Press release: European Medicines Agency recommends approval of sofosbuvir for the treatment of chronic hepatitis C |
| Name of medicine | Tivicay |
|---|---|
| INN | dolutegravir |
| Marketing-authorisation applicant | ViiV Healthcare |
| Therapeutic indication | Treatment of Human Immunodeficiency Virus (HIV) |
| More information |
CHMP summary of positive opinion for Tivicay Press release: European Medicines Agency recommends approval of new HIV medicine |
| Name of medicine | Xigduo |
|---|---|
| INN | dapagliflozin, metformin |
| Marketing-authorisation applicant | Bristol-Myers Squibb / AstraZeneca EEIG |
| Therapeutic indication | Treatment of type 2 diabetes mellitus |
| More information | CHMP summary of positive opinion for Xigduo |
Negative recommendation on new medicines
| Name of medicine | Masican |
|---|---|
| INN | masitinib |
| Marketing-authorisation holder | AB Science |
| Therapeutic indication indication | Treatment of gastrointestinal stromal tumours (GIST) |
| More information | Questions and answers on refusal of the marketing authorisation for Masican |
Positive recommendation on new generic medicine
| Name of medicine | Zoledronic Acid Accord |
|---|---|
| INN | zoledronic acid |
| Marketing-authorisation applicant | Accord Healthcare Limited |
| Therapeutic indication | Prevention of skeletal-related events and treatment of tumour-induced hypercalcaemia (TIH) |
| More information | CHMP summary of positive opinion for Zoledronic Acid Accord |
Update of previous opinion
| Name of medicine | Tecfidera |
|---|---|
| INN | dimethyl fumarate |
| Marketing-authorisation applicant | Biogen Idec ltd |
| Therapeutic indication | Treatment of multiple sclerosis |
| More information | CHMP summary of positive opinion for Tecfidera |
Re-examination of initial recommendation for marketing authorisation
| Name of medicine | Deltyba |
|---|---|
| INN | delamanid |
| Marketing-authorisation applicant | Otsuka Novel Products GmbH |
| Therapeutic indication | Treatment of multidrug-resistant pulmonary tuberculosis |
| More information |
CHMP summary of positive opinion for Deltyba Press release: European Medicines Agency recommends two new treatment options for tuberculosis |
Positive recommendations on extensions of therapeutic indications
| Name of medicine | Abraxane |
|---|---|
| INN | paclitaxel |
| Marketing-authorisation holder | Celgene Europe Limited |
| More information |
CHMP post-authorisation summary of positive opinion for Abraxane Press release: European Medicines Agency recommends extending use of Abraxane to include treatment of pancreatic cancer |
| Name of medicine | Pradaxa |
|---|---|
| INN | dabigatran etexilate |
| Marketing-authorisation holder | Boehringer Ingelheim International GmbH |
| More information | CHMP post-authorisation summary of positive opinion for Pradaxa |
| Name of medicine | Velcade |
|---|---|
| INN | bortezomib |
| Marketing-authorisation holder | Janssen-Cilag International N.V. |
| More information | CHMP post-authorisation summary of positive opinion for Velcade |
Recommendations on new contraindications
| Name of medicine | Corlentor |
|---|---|
| INN | ivabradine |
| Marketing-authorisation holder | Les Laboratoires Servier |
| More information | CHMP post-authorisation summary of positive opinion for Corlentor |
| Name of medicine | Procoralan |
|---|---|
| INN | ivabradine |
| Marketing-authorisation holder | Les Laboratoires Servier |
| More information | CHMP post-authorisation summary of positive opinion for Procoralan |
Compassionate use
| Name of medicine | Daclatasvir |
|---|---|
| INN | daclatasvir |
| Manufacturer | Bristol Myers Squibb |
| More information | Press release: European Medicines Agency advises on compassionate use of daclatasvir |
Other opinion
| Name of medicine | Erbitux |
|---|---|
| INN | cetuximab |
| Marketing-authorisation holder | Merck KGaA |
| More information | CHMP post-authorisation summary of positive opinion for Erbitux |
Public-health recommendations
| Name of medicine | Combined hormonal contraceptives |
|---|---|
| More information |
| Name of medicine | Iclusig |
|---|---|
| More information | European Medicines Agency recommends changes in use of leukaemia medicine Iclusig (ponatinib) in order to minimise risk of blood clots |
| Name of medicine | Thiocolchicoside |
|---|---|
| More information |
Thiocolchicoside: Article-31 referral European Medicines Agency recommends restricting use of thiocolchicoside by mouth or injection |
Other updates
| Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures adopted at the CHMP meeting 18-21 November 2013 |
| Opinions on safety variations / periodic safety update reports adopted at the CHMP meeting 18-21 November 2013 |
| Start of Community reviews |
| Scientific advice and protocol assistance adopted during the CHMP meeting 18 – 21 November 2013 |
| Guidelines and concept papers adopted at the CHMP meeting 18-21 November 2013 |
| Overview of invented names reviewed in November 2013 by the Name Review Group (NRG) |
| Organisational matters: adopted at the CHMP meeting 18-21 November 2013 |
| Opinions on consultation procedures on ancillary medicinal substances in medical devices |