The European Medicines Agency (EMA) has recommended five medicines for approval at its July 2019 meeting, which took place from 22-25th of July.
The organisation’s Committee for Medicinal Products for Human Use firstly recommended granting a conditional marketing authorisation for Bayer’s Vitrakvi (larotrectinib), the first ‘histology-independent’ treatment in the European Union for solid tumours with a neurotrophic tyrosine receptor kinase (NTRK) gene fusion.
The committee also granted a positive opinion for GW Pharma’s Epidyolex (cannabidiol) for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome, two forms of epilepsy.
The drug contains an active substance derived from cannabis and is the first to receive a positive opinion in the EU centralised procedure.
Up next, Acorda Theraputics’ Inbrija (levodopa) received a positive opinion for the treatment of symptoms of ‘off’ periods in Parkinson’s disease and a positive opinion was adopted for Theratechnologies’ Trogarzo (ibalizumab), for the treatment of HIV infection.
Finally, the CHMP recommended Deferasirox Mylan (deferasirox), a generic medicine 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.
Asides from positive opinions, the group has also agreed to re-examine Amgen’s cone drug Evenity (romosozumab) after a negative opinion for this medicine was adopted at the June 2019 meeting.
The meeting also produced eight recommendations on extensions of therapeutic indication, including Bristol-Myers Squibb’s Empliciti (elotuzumab), MSD’s blockbuster cancer drug Keytruda (pembrolizumab), Servier’s Lonsurf (trifluridine-tipiracil hydrochloride), Janssen’s Stelara (ustekinumab) and Roche’s Tecentriq (atezolizumab) among others.
Finally, a recommendation was made that multiple sclerosis medicine Novartis’ Gilenya (fingolimod) must not be used in pregnant women and in women able to have children who are not using effective contraception because the active substance in Gilenya, fingolimod, can harm the unborn baby and may cause birth defects.
The full agenda of the July 2019 meeting is published on EMA's website.