dm+d

703786007

Medicine Compliance Aid Stability

AubagioGenzyme

Genzyme
Aubagio
Tablets f/c 14mg
A3 · Amber 3No stability data is available. There are theoretical concerns with use in CAs, which may be mitigated by risk minimisation.
Airtight container
Protect from moisture
Keep in original package to protect from moisture
9 October 2015

New Medicines

Aubagio Relapsing-remitting multiple sclerosis in children aged 10-17 years - new 7mg tablet formulation

Information

Aubagio
New formulation and licence extension / variation
Genzyme Therapeutics
Sanofi Genzyme

Development and Regulatory status

Approved (Licensed)
Launched
Pre-registration (Filed)
Sep 21Sanofi has yet to set a UK launch date for the 7mg tablet formulation [11].
Sep 21MHRA also approves a 7mg film-coated tablet formulation of Aubagio licensed for treatment of adult patients and paediatric patients aged 10 years and older with RRMS [10].
Sep 21MHRA approves a licence extension for Aubagio 14mg tablets to include use in paediatric patients aged 10 years and older with relapsing remitting multiple sclerosis (previously only licensed for use in adults) [9].
Jun 21Approved in EU [8].
Apr 21A new 7mg film-coated tablet and use from age 10 years recommended for EU approval by CHMP - the amended indication is "treatment of adult patients and paediatric patients aged 10 years and older with relapsing remitting multiple sclerosis (MS).” [7]
Jul 20Filed for relapsing MS in paediatric patients; no information available on country of filing - presume US [6].
Jul 18Filings planned for 2020 [3].

Category

Dihydroorotate dehydrogenase (DHODH) inhibitor that blocks the proliferation and function of activated T and B lymphocytes
5-10% of people with MS experienced their first symptoms before the age of 16. Prevalence of MS recorded in the UK from 1990 to 2010 increased by about 2.4% per year, reaching 285.8 per 100 000 in women and 113.1 per 100 000 in men by 2010 [1,2].
Relapsing-remitting multiple sclerosis in children aged 10-17 years - new 7mg tablet formulation
Oral

Trial or other data

Dec 20PIII TERIKIDS (NCT02201108) still recruiting with an estimated completion date of Dec 2020 [5].
Aug 18Recruitment is complete in PIII TERIKIDS trial [4].
Jun 14PIII TERIKIDS trial to evaluate efficacy, safety, tolerability, and pharmacokinetics of teriflunomide administered orally once-daily in paediatric patients with relapsing forms of multiple sclerosis starts (NCT02201108). The primary endpoint is assessment of time to first clinical relapse after randomisation, assessed over 96 weeks. 166 children aged 10-17 years will be enrolled in countries around the world including the US & EU (incl. UK). Collection of primary outcome data is expected to complete Dec 19 [4].