Five new medicines recommended for approval

EMA’s human medicines committee (CHMP) recommended five medicines for approval at its July 2019 meeting.

The Committee recommended granting a conditional marketing authorisation for Vitrakvi* (larotrectinib), the first ‘histology-independent’ treatment in the European Union for solid tumours with a neurotrophic tyrosine receptor kinase (NTRK) gene fusion. NTRK gene fusions occur very frequently in a number of rare cancers. For more information, please see the press release in the grid below.

The CHMP granted a positive opinion for Epidyolex* (cannabidiol) for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome, two forms of epilepsy. Epidyolex contains an active substance derived from cannabis and is the first to receive a positive opinion in the EU centralised procedure.

Inbrija (levodopa) received a positive opinion for the treatment of symptoms of ‘off’ periods in Parkinson’s disease.

The Committee adopted a positive opinion for Trogarzo (ibalizumab), for the treatment of HIV infection.

The CHMP recommended for approval the generic medicine Deferasirox Mylan (deferasirox), for the treatment of chronic iron overload due to blood transfusions in patients with beta thalassaemia major, non-transfusion-dependent thalassaemia syndromes and other anaemias.

Start of re-examination of recommendation for new medicine

The applicant for Evenity (romosozumab) has requested a re-examination of the Committee’s negative opinion for this medicine adopted at the June 2019 meeting. The CHMP will re-examine the opinion and issue a final recommendation. For more information on this negative opinion, please see the question-and-answer document in the grid below.

Eight recommendations on extensions of therapeutic indication

The Committee recommended extensions of indication for Empliciti, Keytruda, Lonsurf, Lucentis, Soliris, Stelara, Tecentriq and Zerbaxa.

Start of re-examination of recommendations on extension of therapeutic indications

The applicants for Revolade (eltrombopag) and Translarna (ataluren) have requested re-examination of the Committee’s negative opinions for these medicines adopted at the June 2019 meeting. The CHMP will re-examine the opinions and issue final recommendations. For more information on these negative opinions, please see the question-and-answer documents in the grid below.

Updated restrictions for c

The CHMP recommended that the multiple sclerosis medicine Gilenya (fingolimod) must not be used in pregnant women and in women able to have children who are not using effective contraception. If a woman becomes pregnant while using Gilenya, the medicine must be stopped and the pregnancy will have to be closely monitored. This is because the active substance in Gilenya, fingolimod, can harm the unborn baby and may cause birth defects. For more information, please see the public health recommendation in the grid below.

Posted on the EMA website on 26 July 2019