Three new medicines, including one orphan, recommended for approval

Three new medicines have been recommended for approval at the February 2015 meeting of the Committee for Medicinal Products for Human Use (CHMP).

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,HumiraSolirisSustiva 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.


Posted on the EMA website on 27 February 2015