Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 December 2013
Publication of CHMP agendas and minutes
The CHMP agenda was published for the first time during the December 2013 meeting. The minutes of the December 2013 CHMP meeting will be published in January 2014. It will then be standard practice to publish the CHMP agenda at the start of each meeting and the minutes after their adoption the following month. For more information, see the press release published earlier this week.
The agenda of the CHMP undergoes continuous changes as the meeting progresses; this means, for example, that although a medicine is marked in the agenda as due for opinion, the Committee may decide to postpone adoption of its opinion if deemed necessary. All outcomes of the CHMP meeting will be included in the meeting minutes.
Five medicines recommended for approval
The CHMP has recommended granting a conditional marketing authorisation for Sirturo (bedaquiline) for use as part of a combination therapy for pulmonary multidrug-resistant tuberculosis in adults when an effective treatment regime cannot otherwise be composed for reasons of resistance or tolerability. Sirturo has an orphan designation. See the press release in the grid below for more details.
The Committee gave a positive recommendation for Izba (travoprost) for the treatment of ocular hypertension and open-angle glaucoma.
The Committee also recommended the granting of a marketing authorisation for Mirvaso (brimonidine) for the treatment of facial erythema of rosacea in adults.
The Committee recommended the granting of a marketing authorisation for Neuraceq (florbetaben (18F)) for the detection of beta-amyloid in the brain in patients being evaluated for Alzheimer's disease and other causes of cognitive impairment.
Positive scientific opinion on Tritanrix HB (Article 58)
The CHMP adopted a positive scientific opinion in accordance with Article 58 of Regulation (EC) No 726/2004 for Tritanrix HB for immunisation against diphtheria, tetanus, pertussis and hepatitis B in infants from six weeks onwards. Article 58 establishes a mechanism whereby the European Medicines Agency (EMA) can give a scientific opinion, in the context of cooperation with the World Health Organisation, for the evaluation of medicines for human use that are intended exclusively for markets outside the European Union (EU). Medicines eligible for this procedure are used to prevent or treat diseases of major public health interest. Tritanrix HB is no longer used in the EU and its EU marketing authorisation will cease to be valid at the end of 2013. The request was submitted to the EMA by the applicant under Article 58 in order to avoid an interruption in the availability of the vaccine outside the EU, where it is still used in several countries.
Negative opinion on Winfuran
The Committee adopted a negative opinion for Winfuran (nalfurafine), an orphan medicine which was intended for the treatment of uraemic pruritus in patients with end-stage kidney disease on dialysis.
Recommendation on extension of therapeutic indication
Outcome of two safety reviews
The CHMP issued recommendations on Estradiol (topical use) and Kogenate / Helixate NexGen.
Re-examination of Masican
The applicant for Masican has requested a re-examination of the CHMP's November 2013 negative opinion. Upon receipt of the grounds for the request, the CHMP will re-examine its opinion and issue a final recommendation.
Withdrawal of application for extension of therapeutic indication
A question-and-answer document on the withdrawal of an application for extension of indication for Exelon / Prometax is also published below.
More information on these and other outcomes of this month's meeting are available in the table below. All other outcomes of the December CHMP meeting will be included in the meeting minutes to be published in January 2014.
Positive recommendations on new medicines
|Name of medicine||Cometriq|
|International non-proprietary name (INN)||cabozantinib|
|Marketing-authorisation applicant||TMC Pharma Services Ltd|
|Therapeutic indication||Treatment of medullary thyroid carcinoma|
|More information||Summary of opinion for Cometriq|
|Name of medicine||Izba|
|Marketing-authorisation applicant||Alcon Laboratories (UK) Ltd|
|Therapeutic indication||Treatment of ocular hypertension and open-angle glaucoma|
|More information||Summary of opinion for Izba|
|Name of medicine||Mirvaso|
|Marketing-authorisation applicant||Galderma International|
|Therapeutic indication||Treatment of facial erythema of rosacea in adult patients|
|More information||Summary of opinion for Mirvaso|
|Name of medicine||Neuraceq|
|Marketing-authorisation applicant||Piramal Imaging GmbH|
|Therapeutic indication||Detection of β-amyloid in the brain|
|More information||Summary of opinion for Neuraceq|
|Name of medicine||Sirturo|
|Marketing-authorisation applicant||Janssen-Cilag International N.V.|
|Therapeutic indication||Treatment of pulmonary tuberculosis|
|More information||Summary of opinion for Sirturo|
European Medicines Agency recommends approval of a new medicine for multidrug-resistant tuberculosis
|Name of medicine||Tritanrix HB|
|Common name||diphtheria (d), tetanus (t), pertussis (whole cell) (pw) and hepatitis B (rdna) (hbv) vaccine (adsorbed)|
|Marketing-authorisation applicant||GlaxoSmithKline Biologicals S.A.|
|Therapeutic indication||Active immunisation against diphtheria, tetanus, pertussis and hepatitis B|
|More information||Summary of opinion for Tritanrix HB - submitted under Article 58 for use outside the European Union|
Negative recommendation on new medicine
|Name of medicine||Winfuran|
|Marketing-authorisation applicant||Toray International U.K. Limited|
|Therapeutic indication||Treatment of uraemic pruritus|
|More information||Questions and answers on refusal of the marketing authorisation for Winfuran|
Positive recommendation on extension of therapeutic indication
|Name of medicine||Jentadueto|
|INN||linagliptin / metformin|
|Marketing-authorisation holder||Boehringer Ingelheim International GmbH|
|More information||Summary of opinion for Jentadueto|
Withdrawal of application for extension of therapeutic indication
|Name of medicine||Exelon / Prometax|
|Marketing-authorisation holder||Novartis Europharm Ltd|
|More information||Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Exelon and Prometax|
|Name of medicine||Estradiol (topical use)|
|Name of medicine||Helixate NexGen / Kogenate Bayer|
|More information||Helixate NexGen / Kogenate Bayer|
Outcomes of arbitration procedures
|Name of medicine||Nanotop|
|INN||human albumin, denatured [NanoHSA]|
|Name of medicine||Tibolona Aristo / Tibocina|
|More information||Tibolona Aristo / Tibocina|
|Name of medicine||Valebo|
|INN||alendronic acid and alfacalcidol|