human medicines - European Medicines Agency - Europa EU

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Issue 76 June 2015

HUMAN MEDICINES

HIGHLIGHTS Key information for patients, consumers and healthcare professionals Published monthly by the European Medicines Agency

An agency of the European Union

This newsletter is addressed primarily to organisations representing patients, consumers and healthcare IN THIS ISSUE

professionals. It provides a summary of key information relating to medicines for human use published

Antivirals/anti-infectives

1

during the previous month by the European Medicines Agency.

Cancer

1

Information is selected based on recommendations from consulted patients, consumers and healthcare

Cardiovascular system

2

Dermatology

2

Diabetes

3

Haematology

3

desktop news reader. For a list of RSS readers please refer to our RSS guide and follow the instructions

Hormone system

3

from the selected RSS reader in order to add our newsletter feed.

Immune system

3

Metabolic system

3

Musculoskeletal system

4

Nephrology

4

Nervous system

4

Ophthalmology

5

Respiratory system

5

professionals, and does not necessarily cover all relevant information published by the Agency. To receive each new issue of the newsletter, please click here RSS feeds, choose ‘Human medicines highlights newsletter’ and then click on ‘Subscribe to this feed’. Please note, in order to be able to view RSS feeds you need one of the following: a modern web browser; a web-based news reader or a

Information on medicines Antivirals/anti-infectives New medicines authorised 

Medicines under additional monitoring

5

Guidelines

5

Scientific committee and

Treatment of fungal infections

Arbitration procedures 

working party activities

6

Other publications

6

Explanation of terms used

8

Voriconazole Hospira (voriconazole)

Amoxil (amoxicillin) - outcome Treatment of bacterial infections

Cancer Positive CHMP opinions on new medicines 

Docetaxel Hospira UK Limited (docetaxel) Treatment of breast cancer, non-small lung cancer, prostate cancer, gastric adenocarcinoma, and head and neck cancer

Key to symbols used Orphan medicine

Generic medicine

Biosimilar medicine

Conditional approval

Exceptional circumstances

HUMAN MEDICINES

HIGHLIGHTS 

Issue 76 June 2015

Page 2

Farydak (panobinostat) Treatment of multiple myeloma



Odomzo (sonidegib) Treatment of basal cell carcinoma (a type of skin cancer)

New medicines authorised 

Akynzeo (netupitant / palonosetron) Prevention of nausea and vomiting associated with chemotherapy



Lenvima (lenvatinib) Treatment of thyroid cancer



Zykadia (ceritinib) Treatment of non-small cell lung cancer

New information on authorised medicines 

Perjeta (pertuzumab) - new indication Treatment of breast cancer

Withdrawal of authorised medicines 

Docetaxel Mylan (docetaxel) Treatment of breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma and head and neck cancer

Cardiovascular system New medicines authorised 

Kengrexal (cangrelor) Reduction of problems caused by blood clots, such as heart attack

Safety communication update 

Review of hydroxyzine-containing medicines - CMDh Position (new measures to minimise known heart risks) Various uses including relief of anxiety disorders, relief of pruritus (itching), premedication before surgery, and treatment of sleep disorders

Dermatology New information on authorised medicines 

Humira (adalimumab) - new indication Treatment of hidradenitis suppurativa (chronic skin disease that causes abscesses and scarring on the skin)

Safety communication update 

Review of hydroxyzine-containing medicines - CMDh Position (new measures to minimise known heart risks) Various uses including relief of anxiety disorders, relief of pruritus (itching), premedication before surgery, and treatment of sleep disorders

Key to symbols used Orphan medicine

Generic medicine

Biosimilar medicine

Conditional approval

Exceptional circumstances

HUMAN MEDICINES

HIGHLIGHTS

Issue 76 June 2015

Page 3

Diabetes New medicines authorised 

Synjardy (empagliflozin / metformin) Treatment of type 2 diabetes mellitus

New information on authorised medicines 

Levemir (insulin detemir) - change in indication Treatment of diabetes mellitus

Safety communication update 

Review of SGLT2 inhibitors (canagliflozin, dapagliflozin, empagliflozin) - review started (risk of diabetic ketoacidosis to be examined) Treatment of type 2 diabetes mellitus

Haematology Positive CHMP opinions on new medicines 

Farydak (panobinostat) Treatment of multiple myeloma

New information on authorised medicines 

Voncento (human coagulation factor VIII / von Willebrand factor) - change in indication Prevention and treatment of haemorrhage or surgical bleeding in patients with von Willebrand disease

Hormone system Withdrawal of applications for new medicines 

Corluxin (mifepristone) Intended for the treatment of Cushing’s syndrome

Immune system Safety communication update 

Review of adrenaline auto-injectors (epinephrine) - CHMP Opinion (training tools recommended to support patients) Treatment of anaphylaxis (severe allergic reactions)

Metabolic system Positive CHMP opinions on new medicines 

Kanuma (sebelipase alfa) Treatment of lysosomal acid lipase deficiency



Strensiq (asfotase alfa) Treatment of paediatric-onset hypophosphatasia (a rare inherited bone disorder)

Key to symbols used Orphan medicine

Generic medicine

Biosimilar medicine

Conditional approval

Exceptional circumstances

HUMAN MEDICINES

HIGHLIGHTS 

Issue 76 June 2015

Page 4

EMA recommends measures to ensure safe and effective use of Strensiq

Withdrawal of authorised medicines 

Kolbam (previously Cholic Acid FGK) (cholic acid) Used for the treatment of inborn errors in primary bile acid synthesis (defects in bile acid production)

Negative CHMP opinions on new medicines 

Heparesc (human heterologous liver cells) Intended for the treatment of urea cycle disorders

Musculoskeletal system Positive CHMP opinions on new medicines 

Strensiq (asfotase alfa) Treatment of paediatric-onset hypophosphatasia (a rare inherited metabolic disorder affecting the bones

Nephrology New medicines authorised 

Jinarc (tolvaptan) Treatment of polycystic kidney disease

Nervous system Positive CHMP opinions on new medicines 

Aripiprazole Sandoz (aripiprazole) Treatment of schizophrenia and prevention of manic episodes in bipolar I disorder



Duloxetine Zentiva (duloxetine) Treatment of major depressive disorder, diabetic nerve pain and generalised anxiety disorder



Pregabalin Accord (pregabalin) Treatment of epilepsy and generalised anxiety disorder

New medicines authorised 

Duloxetine Mylan (duloxetine) Treatment of major depressive disorder, diabetic nerve pain and generalised anxiety disorder

Safety communication update 

Review of hydroxyzine-containing medicines - CMDh Position (new measures to minimise known heart risks) Various uses including relief of anxiety disorders, relief of pruritus (itching), premedication before surgery, and treatment of sleep disorders

Key to symbols used Orphan medicine

Generic medicine

Biosimilar medicine

Conditional approval

Exceptional circumstances

HUMAN MEDICINES

HIGHLIGHTS

Issue 76 June 2015

Page 5

Ophthalmology Positive CHMP opinions on new medicines 

Raxone (idebenone) Treatment of visual impairment in patients with Leber’s hereditary optic neuropathy

Respiratory system Positive CHMP opinions on new medicines 

Respreeza (human alpha1-proteinase inhibitor) Treatment of alpha 1-proteinase inhibitor deficiency (a condition mainly affecting the lungs)

New medicines authorised 

Quinsair (levofloxacin) Management of chronic pulmonary infections in patients with cystic fibrosis

Medicines under additional monitoring 

List of medicinal products under additional monitoring

Other information Guidelines Guidelines open for consultation 

Draft guideline on the clinical investigation of recombinant and human plasma-derived factor VIII products Deadline for comments: 1 July 2015



Draft guideline on core summary of product characteristics for human plasma derived and recombinant coagulation factor VIII products Deadline for comments: 1 July 2015



Draft guideline on epidemiological data on blood transmissible infections Deadline for comments: 31 August 2015



Reflection paper on assessment of cardiovascular risk of medicinal products for the treatment of cardiovascular and metabolic diseases Deadline for comments: 30 September 2015



Draft guideline on clinical investigation of medicinal products other than non-steroidal anti-inflammatory drugs (NSAIDs) for treatment of rheumatoid arthritis Deadline for comments: 29 November 2015



Paediatric addendum on the CHMP guideline on clinical investigation of medicinal products for the treatment of acute heart failure, Deadline for comments: 30 November 2015

Key to symbols used Orphan medicine

Generic medicine

Biosimilar medicine

Conditional approval

Exceptional circumstances

HUMAN MEDICINES

HIGHLIGHTS

Issue 76 June 2015

Page 6

Adopted guidelines 

Guideline on clinical investigation of recombinant and human plasma-derived factor IX products



Guideline on core SmPC for plasma-derived fibrin sealant / haemostatic products



Reflection paper on classification of advanced therapy medicinal products



Guideline on clinical investigation of medicinal products for the treatment of acute heart failure



Reflection paper on good-clinical-practice compliance in relation to trial master files (paper and / or electronic) for management, audit and inspection of clinical trials - updated



Guideline on the investigation of drug interactions - updated



Guideline on bioanalytical method validation - updated

Scientific committee and working party activities 

Medicinal products for human use: monthly figures - April 2015



Medicinal products for human use: monthly figures - May 2015



CHMP - agendas, minutes and highlights



CHMP applications for new human medicines: June 2015



CAT - agendas, minutes and reports



COMP - agendas, minutes and meetings reports



HMPC - agendas, minutes and meetings reports



PDCO - agendas, minutes and meeting reports



PRAC - agendas, minutes and highlights



PRAC recommendations on safety signals



Work plan for the Safety Working Party 2015 - updated



Annual report of the GMD and GDP Inspectors Working Group 2014

Other publications 

EMA Management Board: highlights of June 2015 meeting



Management Board meeting dates 2015-2018



Publication of clinical data



Facilitating the development of advanced therapies



Central repository for safety reports - one year to go before mandatory use



Early dialogue to support development of medicines for children



PCWP and HCPWP joint meeting: Information session on biosimilars - Mar 2015 - video recording



EU International Organization for Standardization (ISO) identification of medicinal products (IDMP) Task Force meeting - meeting documents

Key to symbols used Orphan medicine

Generic medicine

Biosimilar medicine

Conditional approval

Exceptional circumstances

HUMAN MEDICINES

HIGHLIGHTS 

Issue 76 June 2015

Page 7

Applying regulatory science to neonates: launch of the International Neonatal Consortium (INC) meeting documents



Annual workshop of the Enpr-EMA - meeting documents



Workshop on the therapeutic use of bacteriophages - meeting documents



Fourth industry stakeholder platform - operation of EU pharmacovigilance legislation - meeting documents



EU International Organization for Standardization (ISO) identification of medicinal products (IDMP) Task Force meeting - June 2015



Joint EMA/DIA information day on International Organization for Standardization identification of medicinal products standards: achieving compliance - June 2015



Joint EMA/DIA information day on risk management planning - June 2015

Key to symbols used Orphan medicine

Generic medicine

Biosimilar medicine

Conditional approval

Exceptional circumstances

HUMAN MEDICINES

HIGHLIGHTS

Issue xx Month 2015

Page 8

Explanation of terms used Orphan medicine A medicine intended for the treatment of a rare, serious disease.

Generic medicine A medicine that is essentially the same as one that has already been authorised for use. (The latter is known as the 'reference medicine')

Biosimilar medicine A biological medicine that is similar to another biological medicine which has already been authorised for use. (Biosimilar medicines are also known as 'similar biological' medicines)

Conditional approval A medicine that fulfils an unmet medical need may, if its immediate availability is in the interest of public health, be granted a conditional marketing authorisation on the basis of less complete clinical data than are normally required, subject to specific obligations being imposed on the authorisation holder.

Exceptional circumstances A medicine may be approved in some cases where the applicant cannot provide comprehensive data on the safety or efficacy of the medicine under normal conditions of use, due to exceptional circumstances such as ethical issues or the rarity of the disease concerned.

Note on the centralised authorisation procedure To obtain a single marketing authorisation (licence) for a medicine that is valid in all Member States of the European Union (EU) – via a process known as the 'centralised procedure' – the company or person developing the medicine must submit an application to the European Medicines Agency.

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The Agency's Committee for Medicinal Products for Human Use (CHMP) carries out a scientific evaluation of the information contained in the application and prepares an opinion (scientific recommendation). The Agency transmits this (positive or negative) opinion to the European Commission, which then issues a Decision granting or refusing the marketing authorisation.

http://www.ema.europa.eu

When the CHMP adopts a positive opinion on a medicine, the Agency publishes on its website a 'summary of opinion', in the first instance, followed by more detailed information in a 'European public assessment report (EPAR)' after the marketing authorisation has been granted.

Healthcare professionals

Further information about the European Medicines Agency and the work it does is available on our website:

In particular, you may be interested in these links: About us Patients and carers

European public assessment reports

European Medicines Agency 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 E-mail [email protected] Website www.ema.europa.eu

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© European Medicines Agency, 2015. Reproduction is authorised provided the source is acknowledged.