Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 February 2014

 

Ten new medicines recommended for approval

 

London, UK (February 21, 2014) – The CHMP has recommended granting a paediatric-use marketing authorisation (PUMA) for Hemangiol (propranolol) for the treatment of proliferating infantile haemangioma. This is the second time that the Committee has granted a positive opinion for a PUMA since the introduction of this type of marketing authorisation by the Paediatric Regulation, which came into force in 2007. Please see press release on the website for more information.

 

This month, a number of medicines for the treatment of chronic obstructive pulmonary disease (COPD) were recommended for marketing authorisation by the CHMP.

 

The Committee recommended granting marketing authorisations for six medicines for the treatment of respiratory diseases. Four of these, Anoro (umeclidinium bromide / vilanterol) and Laventair (umeclidinium bromide / vilanterol), as well as Incruse (umeclidinium bromide) and Ulunar Breezhaler (indacaterol / glycopyrronium bromide), are intended for the treatment of symptoms in adult patients with COPD. The remaining two, DuoResp Spiromax (budesonide / formoterol) and BiResp Spiromax (budesonide / formoterol), are intended for the treatment of asthma and COPD.

 

In other therapeutic areas, Vimizim (elosulfase alfa) was granted marketing authorisation by the CHMP for the treatment of mucopolysaccharidosis type IVA. Vimizim has an orphan designation.

 

The Committee recommended the granting of a marketing authorisation for Vokanamet (canagliflozin / metformin) for the treatment of type 2 diabetes.

 

Pregabalin Pfizer (pregabalin) was also recommended for approval by the Committee for the treatment of neuropathic pain, epilepsy and general anxiety disorder.

 

 

New compassionate-use programme

 

The CHMP has given an opinion on the use of a fixed-dose combination of ledipasvir and sofosbuvir for the treatment of chronic (long-term) hepatitis C virus (HCV) infection, in a compassionate-use programme. Please see press release on the website for more information.

 

 

Outcome of two safety reviews

 

The CHMP has recommended restricting the use of methysergide-containing medicines due to concerns that it could cause fibrosis, a condition in which fibrous (scar) tissue accumulates in the body’s organs potentially damaging them.

 

The outcome of the safety review on Protelos/Osseor will be published shortly.

 

 

Four requests for re-examination of CHMP recommendations  

 

The marketing authorisation holders for Masiviera, Nerventra, Reasanz and Translarna have requested re-examinations of the CHMP’s negative opinions for these medicines adopted during the January 2014 meeting. Upon receipt of the grounds of the requests for re-examination, the CHMP will re-examine these opinions and issue final opinions.

 

 

Withdrawal of application

 

A questions-and-answers document on the withdrawal of marketing authorisation application for Heplisav is also published below.

 

More information on these and other outcomes of this month’s meeting are available in the table below. 

 

 

CHMP welcomes new member

 

At the February 2014 CHMP, Dimitrios Kouvelas replaced Aikaterini Moraiti as the new CHMP member for Greece.

 

 

Agenda and minutes

 

The agenda of the February 2014 meeting is published on the EMA website. The minutes of the meeting will be published during the week following the March CHMP meeting. Minutes of the January 2014 CHMP meeting will be published next week.

 

For an overview of all information available on the meeting of the CHMP including its full agenda, please click on the below link:

 

 

 


European Medicines Agency, 21.02.2014 (tB).

MEDICAL NEWS

IU School of Medicine researchers develop blood test for anxiety
COVID-19 pandemic increased rates and severity of depression, whether people…
COVID-19: Bacterial co-infection is a major risk factor for death,…
Regenstrief-led study shows enhanced spiritual care improves well-being of ICU…
Hidden bacteria presents a substantial risk of antimicrobial resistance in…

SCHMERZ PAINCARE

Hydromorphon Aristo® long ist das führende Präferenzpräparat bei Tumorschmerz
Sorgen und Versorgen – Schmerzmedizin konkret: „Sorge als identitätsstiftendes Element…
Problem Schmerzmittelkonsum
Post-Covid und Muskelschmerz
Kopfschmerz bei Übergebrauch von Schmerz- oder Migränemitteln

DIABETES

Wie das Dexom G7 abstrakte Zahlen mit Farben greifbar macht…
Diabetes mellitus: eine der großen Volkskrankheiten im Blickpunkt der Schmerzmedizin
Suliqua®: Einfacher hin zu einer guten glykämischen Kontrolle
Menschen mit Diabetes während der Corona-Pandemie unterversorgt? Studie zeigt auffällige…
Suliqua® zur Therapieoptimierung bei unzureichender BOT

ERNÄHRUNG

Positiver Effekt der grünen Mittelmeerdiät auf die Aorta
Natriumaufnahme und Herz-Kreislaufrisiko
Tierwohl-Fleisch aus Deutschland nur mäßig attraktiv in anderen Ländern
Diät: Gehirn verstärkt Signal an Hungersynapsen
Süßigkeiten verändern unser Gehirn

ONKOLOGIE

Strahlentherapie ist oft ebenso effizient wie die OP: Neues vom…
Zanubrutinib bei chronischer lymphatischer Leukämie: Zusatznutzen für bestimmte Betroffene
Eileiter-Entfernung als Vorbeugung gegen Eierstockkrebs akzeptiert
Antibiotika als Störfaktor bei CAR-T-Zell-Therapie
Bauchspeicheldrüsenkrebs: Spezielle Diät kann Erfolg der Chemotherapie beeinflussen

MULTIPLE SKLEROSE

Multiple Sklerose: Aktuelle Immunmodulatoren im Vergleich
Neuer Biomarker für Verlauf von Multipler Sklerose
Multiple Sklerose: Analysen aus Münster erhärten Verdacht gegen das Epstein-Barr-Virus
Aktuelle Daten zu Novartis Ofatumumab und Siponimod bestätigen Vorteil des…
Multiple Sklerose durch das Epstein-Barr-Virus – kommt die MS-Impfung?

PARKINSON

Meilenstein in der Parkinson-Forschung: Neuer Alpha-Synuclein-Test entdeckt die Nervenerkrankung vor…
Neue Erkenntnisse für die Parkinson-Therapie
Cochrane Review: Bewegung hilft, die Schwere von Bewegungssymptomen bei Parkinson…
Technische Innovationen für eine maßgeschneiderte Parkinson-Diagnostik und Therapie
Biomarker und Gene: neue Chancen und Herausforderungen für die Parkinson-Diagnose…