CHMP News – February 2015


Three new medicines recommended for approval

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

The CHMP has recommended the following:

  • Granting a marketing authorisation for an orphan medicine Jinarc (tolvaptan) for the treatment of patients with autosomal dominant polycystic kidney disease.
  • 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.
  • Granting a marketing authorisation for Ristempa (pegfilgrastim), for the treatment of neutropenia.

Recommendations on extensions of therapeutic indications

The CHMP recommended extensions of indication for the following six medicines: Adenuric, Avastin, Humira, Soliris, Sustiva and Vectibix.

Update on GVK Biosciences review

Following the CHMP’s January 2015 recommendations to suspend marketing authorisations 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 CHMP will start a re-examination. The re-examination will conclude within 60 days.

More on the CHMP February 2015 meeting is available on the EMA’s webpages, or here.