Multiple Sclerosis Medicine Gilenya Must Not Be Used In Pregnant Women

EMA’s human medicines committee (CHMP) had recommended five medicines for approval.

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.

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‘This is because the active substance in Gilenya, fingolimod, can harm the unborn baby and may cause birth defects. ’

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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.

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.

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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.

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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.

Eight recommendations on extensions of therapeutic indication

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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 June2019 meeting. The CHMP will re-examine the opinions and issue final recommendations.

Updated restrictions for Gilenya

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.

Agenda and minutes

The agenda of the July 2019 meeting is published on EMA's website. Minutes of the June 2019 CHMP meeting will be published in the coming weeks.

Source-Medindia