Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 September 2014
NewsHuman
Fifteen new medicines and three extensions of indication recommended for approval
Fifteen new medicines have been recommended for approval at the September meeting of the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP).
The Committee recommended a marketing authorisation for Harvoni (sofosbuvir / ledipasvir) for the treatment of chronic hepatitis C in adults. Harvoni belongs to a new generation of antiviral products for chronic HCV infection that have high cure rates and have recently reshaped the treatment landscape for this disease. Please see the press release in the grid below for more information.
Ketoconazole HRA (ketoconazole) was recommended by the CHMP as a new treatment for patients with Cushing's syndrome. Pharmacological options for this condition remain very limited and there is an unmet medical need for additional medicines. Ketoconazole HRA has an orphan designation. Please see the press release in the grid below for more information.
Two medicines were recommended for approval by the CHMP for the treatment of cancer: Vargatef (nintedanib) for the treatment of non-small cell lung cancer and the orphan medicine Cyramza (ramucirumab) for the treatment of gastric cancer. The diagnostic agent Lymphoseek (tilmanocept)was also recommended for the delineation and localisation of sentinel lymph nodes.
Egranli (balugrastim) was recommended by the CHMP for the treatment of chemotherapy-induced neutropenia and Rezolsta (darunavir / cobicistat)received a positive opinion for the treatment of human immunodeficiency virus (HIV).
The CHMP also recommended Trulicity (dulaglutide) for the treatment of type 2 diabetes and Moventig (naloxegol) for the treatment of opioid-induced constipation.
The generic medicine Tadalafil Mylan was recommended by the Committee for the treatment of erectile dysfunction in adult males.
The CHMP granted positive opinions for the medicines Brimica Genuair and Duaklir Genuair (aclidinium / formoterol fumarate dihydrate) for maintenance bronchodilator treatment to relieve symptoms in adults with chronic obstructive pulmonary disease (COPD). These are duplicate applications, meaning that the company provided the same sets of clinical data to support the marketing authorisations of both medicines.
Three hybrid applications received positive recommendations from the Committee: Budesonide / Formoterol Teva and Vylaer Spiromax for the treatment of asthma and severe COPD, and Budesonide / Formoterol Teva Pharma B.V. for the treatment of asthma. The active ingredients in these medicines are budesonide and formoterol. Hybrid applications rely in part on the results of pre-clinical tests and clinical trials for a reference product and in part on new data.
Three recommendations on extensions of therapeutic indications
The Committee recommended an extension of indications for Signifor and two extensions of indication for Prezista.
Outcome of re-examination procedure
The CHMP concluded a re-examination procedure for Avastin, adopting a final negative opinion on a request for an extension of indication in the treatment of adult patients with newly diagnosed glioblastoma.
Review underway concerning conduct of studies at GVK Bio Research Centre, India
The EMA has started a review in relation to findings of non-compliance with good clinical practice (GCP) at GVK Biosciences site in Hyderabad, India. This follows an inspection by the French medicines agency (ANSM) which raised concerns about study data used to support the marketing authorisation applications of generic medicines.
Outcome of benefit-risk review
The CHMP has completed a routine benefit-risk review of the anti-depressant medicine Valdoxan/Thymanax and concluded that its benefits continue to outweigh the risks. However, the Agency has recommended that further measures should be put in place to improve monitoring of liver function during treatment.
Closure of EU manufacturing site for Maci
The EU manufacturing site for the advanced therapy medicine Maci (matrix-applied characterised autologous cultured chondrocytes) has been closed for commercial reasons. Arrangements are in place for existing patients to complete their treatment. Please see communication in the grid below for further information.
Ebola outbreak: EMA to review experimental medicines to support treatment decisions
The EMA has started to review available information on Ebola treatments currently under development. The goal is to provide an overview of the current state of knowledge about the various experimental medicines to support decision-making by health authorities. Please see the press release in the grid below for information.
Patients discuss benefit-risk evaluation of medicines with the CHMP
The EMA has launched a pilot project to involve patients in the assessment of the benefits and risks of medicines in CHMP meetings. Please see press release for more information.
More information on all outcomes of the CHMP's September 2014 meeting is available in the grid below.
Agenda and minutes
The agenda of the September 2014 meeting is published on the EMA website. The minutes of the meeting will be published during the week following the October CHMP meeting.
CHMP statistics
Key figures from the September 2014 CHMP meeting are presented in the graphic below.
Positive recommendations on new medicines
| Name of medicine | Brimica Genuair |
|---|---|
| International non-proprietary name (INN) | aclidinium / formoterol fumarate dihydrate |
| Marketing-authorisation applicant | Almirall S.A |
| Therapeutic indication | Maintenance bronchodilator treatment for airflow obstruction and relief of symptoms in adult patients with chronic obstructive pulmonary disease |
| More information | CHMP summary of positive opinion for Brimica Genuair |
| Name of medicine | Cyramza |
|---|---|
| INN | ramucirumab |
| Marketing-authorisation applicant | Eli Lilly Nederland B.V. |
| Therapeutic indication | Treatment of gastric cancer |
| More information | CHMP summary of positive opinion for Cyramza |
| Name of medicine | Duaklir Genuair |
|---|---|
| INN | aclidinium / formoterol fumarate dihydrate |
| Marketing-authorisation applicant | Almirall S.A |
| Therapeutic indication | Maintenance bronchodilator treatment for airflow obstruction and relief of symptoms in adult patients with chronic obstructive pulmonary disease |
| More information | CHMP summary of positive opinion for Duaklir Genuair |
| Name of medicine | Egranli |
|---|---|
| INN | balugrastim |
| Marketing-authorisation applicant | Teva Pharma B.V. |
| Therapeutic indication | Treatment of chemotherapy-induced neutropenia |
| More information | CHMP summary of positive opinion for Egranli |
| Name of medicine | Harvoni |
|---|---|
| INN | sofosbuvir / ledipasvir |
| Marketing-authorisation applicant | Gilead Sciences International Ltd |
| Therapeutic indication | Treatment of chronic hepatitis C |
| More information | CHMP summary of positive opinion for Harvoni |
| Press release: Harvoni recommended for the treatment of chronic hepatitis C |
| Name of medicine | Ketoconazole HRA |
|---|---|
| INN | ketoconazole |
| Marketing-authorisation applicant | Laboratoire HRA Pharma |
| Therapeutic indication | Treatment of Cushing's syndrome |
| More information | CHMP summary of positive opinion for Ketoconazole HRA |
| Press release: Ketoconazole HRA recommended for approval in Cushing's syndrome |
| Name of medicine | Lymphoseek |
|---|---|
| INN | tilmanocept |
| Marketing-authorisation applicant | Navidea Biopharmaceuticals Limited |
| Therapeutic indication | Used in the delineation and localisation of lymph nodes |
| More information | CHMP summary of positive opinion for Lymphoseek |
| Name of medicine | Moventig |
|---|---|
| INN | naloxegol |
| Marketing-authorisation applicant | AstraZeneca AB |
| Therapeutic indication | Indicated for the treatment of adult patients 18 years and older with opioid-induced constipation including patients with inadequate response to laxatives |
| More information | CHMP summary of positive opinion for Moventig |
| Name of medicine | Rezolsta |
|---|---|
| INN | darunavir / cobicistat |
| Marketing-authorisation applicant | Janssen-Cilag International N.V. |
| Therapeutic indication | Treatment of antiretroviral therapy (ART)-naïve adults and ART-experienced adults with no darunavir (DRV) resistance associated mutations (RAMs) |
| More information | CHMP summary of positive opinion for Rezolsta |
| Name of medicine | Trulicity |
|---|---|
| INN | dulaglutide |
| Marketing-authorisation applicant | Eli Lilly Nederland B.V. |
| Therapeutic indication | Treatment of adults with type 2 diabetes mellitus |
| More information | CHMP summary of positive opinion for Trulicity |
| Name of medicine | Vargatef |
|---|---|
| INN | nintedanib |
| Marketing-authorisation applicant | Boehringer Ingelheim International GmbH |
| Therapeutic indication | Treatment of non-small cell lung cancer |
| More information | CHMP summary of positive opinion for Vargatef |
Positive recommendation on new generic medicine
| Name of medicine | Tadalafil Mylan |
|---|---|
| INN | tadalafil |
| Marketing-authorisation applicant | Generics (UK) Limited |
| Therapeutic indication | Treatment of erectile dysfunction in adult males |
| More information | CHMP summary of positive opinion for Tadalafil Mylan |
Positive recommendations on new hybrid medicines
| Name of medicine | Budesonide / Formoterol Teva |
|---|---|
| INN | budesonide / formoterol |
| Marketing-authorisation applicant | Teva Pharma B.V. |
| Therapeutic indication | Treatment of asthma and treatment of patients with severe chronic obstructive pulmonary disease |
| More information | CHMP summary of positive opinion for Budesonide / Formoterol Teva |
| Name of medicine | Budesonide / Formoterol Teva Pharma B.V. |
|---|---|
| INN | budesonide / formoterol |
| Marketing-authorisation applicant | Teva Pharma B.V. |
| Therapeutic indication | Treatment of asthma |
| More information | CHMP summary of positive opinion for Budesonide / Formoterol Teva Pharma B.V. |
| Name of medicine | Vylaer Spiromax |
|---|---|
| INN | budesonide / formoterol |
| Marketing-authorisation applicant | Teva Pharma B.V. |
| Therapeutic indication | Treatment of asthma and treatment of patients with severe chronic obstructive pulmonary disease |
| More information | CHMP summary of positive opinion for Vylaer Spiromax |
Positive recommendations on extensions of therapeutic indications
| Name of medicine | Prezista |
|---|---|
| INN | darunavir |
| Marketing-authorisation holder | Janssen-Cilag International N.V. |
| More information | CHMP post-authorisation summary of positive opinion for Prezista |
| Name of medicine | Prezista |
|---|---|
| INN | darunavir |
| Marketing-authorisation holder | Janssen-Cilag International N.V. |
| More information | CHMP post-authorisation summary of positive opinion for Prezista |
| Name of medicine | Signifor |
|---|---|
| INN | pasireotide |
| Marketing-authorisation holder | Novartis Europharm Ltd |
| More information | CHMP post-authorisation summary of positive opinion for Signifor |
Negative recommendation on new extension of therapeutic indication
| Name of medicine | Javlor |
|---|---|
| INN | vinflunine ditartrate |
| Marketing-authorisation holder | Pierre Fabre Médicament |
| More information | Questions and answers on refusal of a change to the marketing authorisation for Javlor (vinflunine) |
Outcome of a re-examination
| Name of medicine | Avastin |
|---|---|
| INN | bevacizumab |
| Marketing-authorisation holder | Roche Registration Ltd |
| More information | Questions and answers on the refusal of a change to the marketing authorisation for Avastin (bevacizumab) |
Start of referral
| Name of medicine | GVK Biosciences |
|---|---|
| More information | Start of a review concerning the conduct of studies at GVK Biosciences site in Hyderabad, India |
Public-health recommendations
| Name of medicine | Valdoxan / Thymanax |
|---|---|
| INN | agomelatine |
| Marketing-authorisation holder | Servier (Ireland) Industries Ltd |
| More information | EMA confirms positive benefit-risk for antidepressant Valdoxan/Thymanax (agomelatine) |
| Name of medicine | Maci |
|---|---|
| INN | matrix applied characterised autologous cultured chondrocytes |
| Marketing-authorisation holder | Aastrom Biosciences DK ApS |
| More information | Closure of EU manufacturing site for Maci |
Outcome of harmonisation procedure
| Name of medicine | EMLA Cream |
|---|---|
| INN | lidocaine / prilocaine |
| Marketing-authorisation holder | Astra Zeneca group of companies and associated companies |
| More information | Questions and answers on EMLA Cream |
Opinion on any scientific matter (Article 5(3))
| Name of medicine | Medicinal products under development for the treatment of Ebola |
|---|---|
| More information | Ebola outbreak: EMA to review experimental medicines to support treatment decisions |