Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 February 2015
Three new medicines, including one orphan, recommended for approval
The Committee has recommended granting a marketing authorisation for Jinarc (tolvaptan) for the treatment of patients with autosomal dominant polycystic kidney disease (ADPKD). Jinarc has an orphan designation. For more information please see the press release in the grid below.
The CHMP has recommended granting a conditional marketing authorisation for Zykadia (ceritinib) for the treatment of adult patients with a type of lung cancer called anaplastic lymphoma kinase (ALK) positive non-small cell lung cancer (NSCLC), when the disease is advanced and has already been treated with crizotinib. A conditional marketing authorisation is granted for a medicine that meets unmet medical needs of patients and is in the interest of public health, before all of the formal studies on its efficacy and safety have been completed. It is one of the mechanisms available to the European Medicines Agency (EMA) to facilitate market access for medicines that fulfill unmet medical needs. For more information on Zykadia, please see the press release in the grid below.
The CHMP also granted a positive opinion for the informed consent application Ristempa (pegfilgrastim), for the treatment of neutropenia. In an informed consent application, reference is made to an authorised medicine and the marketing authorisation holder of the reference medicine has given consent to the use of their dossier in the application procedure.
Six recommendations on extensions of therapeutic indication
The Committee recommended extensions of indication for Adenuric, Avastin, Humira, Soliris, Sustiva and Vectibix.
Recommendation on a new formulation for a medicine to treat diabetes
The CHMP recommended the addition of a new formulation to the marketing authorisation of Optisulin (insulin glargine) and a change of its invented name to Toujeo. The new formulation of Toujeo is a higher-strength insulin (300 units/ml). Insulin glargine was first authorised in the European Union as a 100 units/ml formulation as Lantus and Optisulin in June 2000.
Update on GVK Biosciences review
Following the CHMP's January 2015 recommendation to suspend marketing authorisations of a number of medicines for which authorisations were primarily based on clinical studies conducted at GVK Biosciences, some marketing authorisation holders have requested a re-examination. Once the grounds for re-examination are received by EMA from these marketing authorisation holders (the deadline is 30 March 2015), the CHMP will start a re-examination. The re-examination will conclude within 60 days.
Withdrawal of application
An application for an extension of therapeutic indication for Rienso has been withdrawn. A question-and-answer document on this withdrawal is available below.
Agenda and minutes
The agenda of the February 2015 meeting is published on the EMA website. The minutes of the meeting will be published during the week following the March CHMP meeting.
Key figures from the February 2015 CHMP meeting are represented in the graphic below.
More information on this, and all other outcomes of the CHMP February 2015 meeting, is available in the grid below.
Positive recommendation on new medicine
|Name of medicine||Jinarc|
|International non-proprietary name (INN)||tolvaptan|
|Marketing-authorisation applicant||Otsuka Pharmaceutical Europe Ltd|
|Therapeutic indication||Treatment of kidney disease|
|More information||Summary of opinion for Jinarc|
|Press release: Jinarc recommended for approval in rare kidney disease|
|Name of medicine||Zykadia|
|International non-proprietary name (INN)||ceritinib|
|Marketing-authorisation applicant||Novartis Europharm Ltd|
|Therapeutic indication||Treatment of anaplastic lymphomakinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC)|
|More information||Summary of opinion for Zykadia|
|Press release: Zykadia recommended for approval in advanced non small cell lung cancer|
Positive recommendation on new informed-consent application
|Name of medicine||Ristempa|
|Marketing-authorisation applicant||Amgen Europe B.V.|
|Therapeutic indication||Treatment of neutropenia|
|More information||Summary of opinion for Ristempa|
Positive recommendations on new therapeutic indications
|Name of medicine||Adenuric|
|Marketing-authorisation holder||Menarini International Operations Luxembourg S.A.|
|More information||Summary of opinion for Adenuric|
|Name of medicine||Avastin|
|Marketing-authorisation holder||Roche Registration Ltd|
|More information||Summary of opinion for Avastin|
|Name of medicine||Humira|
|Marketing-authorisation holder||AbbVie Ltd.|
|More information||Summary of opinion for Humira|
|Name of medicine||Soliris|
|Marketing-authorisation holder||Alexion Europe SAS|
|More information||Summary of opinion for Soliris|
|Name of medicine||Sustiva|
|Marketing-authorisation holder||Bristol-Myers Squibb Pharma EEIG|
|More information||Summary of opinion for Sustiva|
|Name of medicine||Vectibix|
|Marketing-authorisation holder||Amgen Europe B.V.|
|More information||Summary of opinion for Vectibix|
Withdrawal of application
|Name of medicine||Rienso|
|More information||Questions and answers on Rienso|
|Name of medicine||Toujeo|
|Marketing-authorisation holder||Sanofi-Aventis Deutschland GmbH|
|More information||Summary of opinion for Toujeo|
|Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures|
|Opinions on safety variations|
|Start of Community reviews|
|Scientific advice and protocol assistance|
|Guidelines and concept papers adopted|
|Overview of invented names reviewed in January 2015 by the Name Review Group (NRG)|
|Opinions on consultation procedures on ancillary medicinal substances in medical devices|