Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 December 2015
Nine medicines recommended for authorisation, 93 overall in 2015
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended nine new medicines for marketing authorisation at its December 2015 meeting. This brings the total number of medicines recommended for approval by the CHMP in 2015 to 93.
The CHMP recommended granting a conditional marketing authorisation for Tagrisso (osimertinib) for the treatment of non-small cell lung cancer (NSCLC). The Committee reviewed Tagrisso under EMA's accelerated assessment program. Conditional approval and accelerated assessment are two of the Agency's main mechanisms to facilitate earlier access by patients to medicines that fulfil unmet medical needs. For more information, please see the press release in the grid below.
Another medicine for NSCLC, Portrazza (necitumumab), also received a positive opinion from the Committee.
Neofordex (dexamethasone), a medicine with an orphan designation, received a positive opinion for the treatment of symptomatic multiple myeloma. Neofordex was submitted as a hybrid application. This type of application relies in part on the results of studies carried out with a reference product and in part on new data.
The CHMP recommended granting a marketing authorisation for Feraccru (ferric maltol) for the treatment of iron deficiency anaemia in patients with inflammatory bowel disease.
Zurampic (lesinurad) received a positive opinion from the Committee for the treatment of hyperuricaemia (an excess of uric acid in the blood).
The CHMP recommended granting a marketing authorisation for Vaxelis, a vaccine against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type B.
Iblias and Kovaltry (octocog alfa) received positive opinions for the treatment and prophylaxis of bleeding in patients with haemophilia A. These are duplicate applications, meaning that the company provided the same sets of clinical data to support the marketing authorisation applications of both medicines.
One generic medicine received a positive opinion from the Committee: Caspofungin Accord (caspofungin) for the treatment of fungal infections.
Negative opinion on new medicine
The CHMP adopted a negative opinion for Dropcys (mercaptamine hydrochloride) which was intended to prevent and treat cystinosis affecting the eye. For more information, please see the questions-and-answers document in the grid below.
Six recommendations on extensions of therapeutic indication
The Committee recommended extensions of indication for Brilique, Nplate, Revolade, Tarceva and two extensions of indication for Cyramza.
New advice for doctors and patients on Gilenya
The CHMP gave new advice for doctors and patients to minimise the risk of progressive multifocal leukoencephalopathy (PML) and basal cell carcinoma in patients treated with the multiple sclerosis medicine Gilenya (fingolimod). For more information, please see the public health communication in the grid below.
Update on Xarelto
The CHMP is currently evaluating whether a defect with a blood clotting test device used in a study of the anti-clotting medicine Xarelto (rivaroxaban) had an impact on the study results. The study, called ROCKET-AF, was used to support the approval of Xarelto for patients with non-valvular atrial fibrillation (a type of irregular heartbeat). The CHMP expects to conclude its assessment in the first quarter of 2016. Once finalised, the CHMP assessment report will be made public.
Agenda and minutes
The agenda of the December 2015 meeting is published on EMA's website. Minutes of the November 2015 CHMP meeting will be published next week.
CHMP statistics
Key figures from the December 2015 CHMP meeting are represented in the graphic below.
More information on this, and all other outcomes of the CHMP's December 2015 meeting, is available in the grid below.
Positive recommendations on new medicines
Name of medicine | Feraccru |
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INN | ferric maltol |
Marketing-authorisation applicant | Iron Therapeutics (UK) Ltd |
Therapeutic indication | Treatment of iron deficiency anaemia in patients with inflammatory bowel disease |
More information |
|
Name of medicine | Iblias |
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INN | octocog alfa |
Marketing-authorisation applicant | Bayer Pharma AG |
Therapeutic indication | Treatment and prophylaxis of bleeding in patients with haemophilia A |
More information |
|
Name of medicine | Kovaltry |
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INN | octocog alfa |
Marketing-authorisation applicant | Bayer Pharma AG |
Therapeutic indication | Treatment and prophylaxis of bleeding in patients with haemophilia A |
More information |
|
Name of medicine | Portrazza |
---|---|
INN | necitumumab |
Marketing-authorisation applicant | Eli Lilly Nederland B.V. |
Therapeutic indication | Treatment of squamous non-small cell lung cancer |
More information |
|
Name of medicine | Tagrisso |
---|---|
INN | osimertinib |
Marketing-authorisation applicant | AstraZeneca AB |
Therapeutic indication | Treatment of non-small cell lung cancer |
More information |
Press release: EMA fast-tracks new oral treatment for non-small cell lung cancer |
Name of medicine | Vaxelis |
---|---|
INN | diphtheria, tetanus, pertussis (acellular, component), hepatitis b (rdna), poliomyelitis (inact.) and haemophilus type b conjugate vaccine (adsorbed) |
Marketing-authorisation applicant | Sanofi Pasteur MSD SNC |
Therapeutic indication | Intended for prophylaxis against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type B |
More information |
|
Name of medicine | Zurampic |
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INN | lesinurad |
Marketing-authorisation applicant | AstraZeneca AB |
Therapeutic indication | Treatment of hyperuricaemia |
More information |
|
Negative recommendation on new medicine
Name of medicine | Dropcys |
---|---|
INN | mercaptamine hydrochloride |
Marketing-authorisation applicant | Lucane Pharma |
Therapeutic indication | Treatment of corneal cystine deposits |
More information |
|
Positive recommendation on new generic medicine
Name of medicine | Caspofungin Accord |
---|---|
INN | caspofungin |
Marketing-authorisation applicant | Accord Healthcare Ltd |
Therapeutic indication | Treatment of fungal infections |
More information |
|
Positive recommendation on new hybrid medicine
Name of medicine | Neofordex |
---|---|
INN | dexamethasone |
Marketing-authorisation applicant | Laboratoires CTRS |
Therapeutic indication | Treatment of multiple myeloma |
More information |
|
Positive recommendations on extensions of therapeutic indications
Name of medicine | Brilique |
---|---|
INN | ticagrelor |
Marketing-authorisation holder | AstraZeneca AB |
More information |
|
Name of medicine | Cyramza |
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INN | ramucirumab |
Marketing-authorisation holder | Eli Lilly Nederland B.V. |
More information |
|
Name of medicine | Nplate |
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INN | romiplostim |
Marketing-authorisation holder | Amgen Europe B.V. |
More information |
|
Name of medicine | Revolade |
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INN | eltrombopag / eltrombopag olamine |
Marketing-authorisation holder | Novartis Europharm Ltd |
More information |
|
Name of medicine | Tarceva |
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INN | erlotinib |
Marketing-authorisation holder | Roche Registration Ltd |
More information |
|
Public health recommendation
Name of medicine | Gilenya |
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INN | fingolimod |
Marketing-authorisation holder | Novartis Europharm Ltd |
More information | New recommendations to minimise risks of the rare brain infection PML and a type of skin cancer with Gilenya |