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.
Multiple Sclerosis
Multiple sclerosis can be a severely disabling autoimmune disease that affects the myelin or insulating layer of the nerve fibers and typically has remissions and relapses
Advertisement
‘This is because the active substance in Gilenya, fingolimod, can harm the unborn baby and may cause birth defects. ’
Tweet it Now
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.
![Multiple Sclerosis Treatment and Modify]( "Multiple Sclerosis Treatment and Modify")
Multiple sclerosis is treated with drugs that modify the course of the disease, suppress immunity and relieve symptoms.
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.
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 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
The Committee adopted a positive opinion for Trogarzo (ibalizumab), for the treatment of HIV infection.
Multiple Sclerosis Treatment and Modify
Multiple sclerosis is treated with drugs that modify the course of the disease, suppress immunity and relieve symptoms.
Advertisement
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.
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 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
Quiz on Multiple Sclerosis
Multiple sclerosis is an autoimmune disease that affects nerves and can leave the affected patient completely disabled. Test your knowledge on this condition by taking this quiz.
Advertisement
 Nanotechnology Treatment Shows Promise Against Multiple Sclerosis, Stated StudyNanotechnology treatment was found to reverse multiple sclerosis symptoms in mice, said new research. | Advertisement
|
Advertisement
Recommended Reading
Latest Drug News
Addressing the unmet needs of Parkinson's Disease by providing disease-modifying therapies could bring about a major shift in the way that patients are treated.
Microrobots could swirl through a person's blood stream, search for targeted areas to treat for various ailments.
Supplementation with multivitamins is an inexpensive way for older adults to slow down memory loss.
Some people with an aggressive blood cancer called acute myeloid leukemia (AML) may soon have a new drug option called Ivosidenib that blocks the activity of IDH1 gene.
In case of cardiac failure where the ejection fraction is greater than 40%, sacubitril/valsartan can prove to be quite beneficial