Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 October 2016
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Eight medicines recommended for approval, including four orphan medicines
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended eight medicines for approval at its October meeting.
The CHMP recommended granting a conditional marketing authorisation for Ocaliva (obeticholic acid) for the treatment of primary biliary cholangitis (also known as primary bile cirrhosis). Ocaliva is an orphan-designated medicine. For more information, please see the press release in the grid below.
The Committee recommended granting a conditional marketing authorisation for Venclyxto (venetoclax) for the treatment of adults with chronic lymphocytic leukaemia (CLL). Venclyxto has an orphan designation.
Cystadrops (mercaptamine) was recommended for approval by the CHMP for the treatment of corneal cystine crystal deposits in patients with cystinosis. Cystadrops has an orphan designation.
Rekovelle (follitropin delta) was recommended for approval for controlled ovarian stimulation.
The Committee recommended granting a marketing authorisation for the orphan medicine SomaKit-TOC (edotreotide) for the diagnosis of gastro-entero-pancreatic neuroendrocrine tumours.
Three generic medicines were recommended for approval: Emtricitabine / Tenofovir disoproxil Mylan (emtricitabine / tenofovir disoproxil), Emtricitabine / Tenofovir disoproxil Krka (emtricitabine / tenofovir disoproxil) and Tenofovir disoproxil Mylan (tenofovir disoproxil). These three medicines are intended for the treatment of HIV infection in adults.
Four recommendations on extensions of therapeutic indications
The Committee recommended extensions of indications for Lucentis, Opdivo, Trisenox and Zebinix.
Outcome of review of metformin-containing medicines
The CHMP has concluded that metformin-containing medicines can now be used in patients with moderately reduced kidney function for the treatment of type 2 diabetes. The recommendations are the result of a review by the Committee following concerns that current scientific evidence does not justify a contraindication in patients with moderate reduction of kidney function. Please see the public health communication in the grid below for more information.
CHMP recommends measures to ensure safe use of Keppra oral solution
Several measures have been put in place to ensure that the correct dosing syringe is used to measure Keppra (levetiracetam) oral solution, and thus avoid medication errors. Keppra is a medicine used to treat epilepsy in adults and children. For more information, please see the public health communication in the grid below.
Withdrawals of applications
Applications for marketing authorisations for Ertapenem Hospira (ertapenem), Pemetrexed (as ditromethamine) Hospira (pemetrexed) and Zemfirza (cediranib) have been withdrawn. Questions-and-answers documents on these withdrawals are available in the grid below.
Election of vice-chair of CHMP
The CHMP has elected a new vice-chair, Dr Harald Enzmann, for a three-year mandate. Dr Enzmann, a medical doctor by training, is currently Head of European and International Affairs at the German Federal Institute for Drugs and Medical Devices (BfArM) in Bonn, Germany. He has been a member of the CHMP since 2005.
New CHMP documents to be made available
From October 2016, the annexes to the CHMP meeting agenda and minutes will be made public. These annexes include information on pre-submission issues, post-authorisation procedures, renewals of marketing authorisations and type II variations. These documents will be available on the CHMP: Agendas, minutes and highlights page.
From October 2016, EMA is also publishing the agendas and minutes of the CHMP Organisational Matters (ORGAM) meeting. ORGAM meetings take place one week before the CHMP meetings and cover topics arising from EMA working parties and drafting groups, such as scientific guidelines, as well as topics related to the organisation of the CHMP. The first ORGAM agenda was published last week and is available on the CHMP: Agendas, minutes and highlights page. The minutes will be published after the current month's CHMP plenary meeting on the same page.
From this month EMA will no longer publish the following annexes as part of the CHMP highlights: 'Opinions on safety variations', 'Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures', 'Guidelines and concept papers adopted' and 'Organisational matters'. This information will be included in the minutes of the CHMP meeting which are published approximately one month after the Committee meets.
The agenda of the October 2016 CHMP meeting is published on EMA's website. Minutes of the September 2016 CHMP meeting will be published next week.
CHMP statistics
Key figures from the October 2016 CHMP meeting are represented in the graphic below.
More information on this, and all other outcomes of the CHMP's October 2016 meeting, is available in the grid below.
Positive recommendations on new medicines
| Name of medicine | Cystadrops |
|---|---|
| International non-proprietary name (INN) | mercaptamine |
| Marketing-authorisation applicant | Orphan Europe S.A.R.L. |
| Therapeutic indication | Treatment of corneal cystine crystal deposits in patients with cystinosis |
| More information | CHMP summary of positive opinion for Cystadrops |
| Name of medicine | Ocaliva |
|---|---|
| INN | obeticholic acid |
| Marketing-authorisation applicant | Intercept Pharma Ltd |
| Therapeutic indication | Treatment of primary biliary cholangitis (also known as primary biliary cirrhosis) |
| More information | CHMP summary of positive opinion for Ocaliva
Press release: New medicine for rare, chronic liver disease |
| Name of medicine | Rekovelle |
|---|---|
| INN | follitropin delta |
| Marketing-authorisation applicant | Ferring Pharmaceuticals A/S |
| Therapeutic indication | Indicated for controlled ovarian stimulation |
| More information | CHMP summary of positive opinion for Rekovelle |
| Name of medicine | SomaKit-TOC |
|---|---|
| INN | edotreotide |
| Marketing-authorisation applicant | Advanced Accelerator Applications |
| Therapeutic indication | Diagnosis of gastro-entero-pancreatic neuroendocrine tumours |
| More information | CHMP summary of positive opinion for SomaKit TOC |
| Name of medicine | Venclyxto |
|---|---|
| INN | venetoclax |
| Marketing-authorisation applicant | AbbVie Ltd. |
| Therapeutic indication | Treatment of adult patients with chronic lymphocytic leukaemia |
| More information | CHMP summary of positive opinion for Venclyxto |
Positive recommendations on new generic medicines
| Name of medicine | Emtricitabine / Tenofovir disoproxil Mylan |
|---|---|
| INN | emtricitabine / tenofovir disoproxil |
| Marketing-authorisation applicant | MYLAN S.A.S. |
| Therapeutic indication | Treatment of HIV infection in adults |
| More information | CHMP summary of positive opinion for Emtricitabine/Tenofovir disoproxil Mylan |
| Name of medicine | Emtricitabine / Tenofovir Krka |
|---|---|
| INN | emtricitabine / tenofovir disoproxil |
| Marketing-authorisation applicant | KRKA, d.d., Novo mesto |
| Therapeutic indication | Treatment of HIV infection in adults |
| More information | CHMP summary of positive opinion for Emtricitabine/Tenofovir disoproxil Krka |
| Name of medicine | Tenofovir disoproxil Mylan |
|---|---|
| INN | tenofovir disoproxil |
| Marketing-authorisation applicant | MYLAN S.A.S. |
| Therapeutic indication | Treatment of HIV infection in adults |
| More information | CHMP summary of positive opinion for Tenofovir disoproxil Mylan |
Positive recommendations on extensions of therapeutic indications
| Name of medicine | Lucentis |
|---|---|
| INN | ranibizumab |
| Marketing-authorisation holder | Novartis Europharm Ltd |
| More information | CHMP post-authorisation summary of positive opinion for Lucentis |
| Name of medicine | Opdivo |
|---|---|
| INN | nivolumab |
| Marketing-authorisation holder | Bristol-Myers Squibb Pharma EEIG |
| More information | CHMP post-authorisation summary of positive opinion for Opdivo |
| Name of medicine | Trisenox |
|---|---|
| INN | arsenic trioxide |
| Marketing-authorisation holder | Teva B.V. |
| More information | CHMP post-authorisation summary of positive opinion for Trisenox |
| Name of medicine | Zebinix |
|---|---|
| INN | eslicarbazepine acetate |
| Marketing-authorisation holder | BIAL - Portela & Ca, S.A. |
| More information | CHMP post-authorisation summary of positive opinion for Zebinix |
Public-health recommendations
| Name of the procedure | Metformin and metformin-containing medicines |
|---|---|
| More information | Use of metformin to treat diabetes now expanded to patients with moderately reduced kidney function |
| Name of the procedure | Keppra |
|---|---|
| INN | levetiracetam |
| Marketing-authorisation holder | UCB Pharma SA |
| More information | EMA recommends measures to ensure safe use of Keppra oral solution |
Withdrawals of application
| Name of medicine | Ertapenem Hospira |
|---|---|
| INN | ertapenem |
| More information | Questions and answers on the withdrawal of the marketing authorisation application for Ertapenem Hospira (ertapenem) |
| Name of medicine | Pemetrexed ditromethamine Hospira |
|---|---|
| INN | pemetrexed |
| More information | Questions and answers on the withdrawal of the marketing authorisation application for Pemetrexed ditromethamine Hospira |
| Name of medicine | Zemfirza |
|---|---|
| INN | cediranib |
| More information | Questions and answers on the withdrawal of the marketing authorisation application for Zemfirza (cediranib) |
Other updates