Teva Pharmaceutical Industries and Active Biotech have announced that both companies remain committed to the Nerventra(laquinimod)clinical development program for multiple sclerosis(MS)following the announcement of a negative opinion for the treatment of relapsing-remitting multiple sclerosis(RRMS)by the Committee for Medicinal Products for Human Use(CHMP)of the European Medicines Agency(EMA).
The CHMP has concluded that the risk-benefit profile of NERVENTRA is not favorable at this time.In accordance with European regulations,Teva and Active Biotech intend to request a re-examination of the CHMP opinion.
Teva and Active Biotech are focusing on evaluating the CHMP's review and will continue to liaise closely with the EMA in working to make Nerventra available as a new treatment option for patients with RRMS in Europe.
The CHMP has concluded that the risk-benefit profile of Nerventra is not favorable at this time.In accordance with European regulations,Teva and Active Biotech intend to request a re-examination of the CHMP opinion.
Teva and Active Biotech are focusing on evaluating the CHMP's review and will continue to liaise closely with the EMA in working to make Nerventra available as a new treatment option for patients with RRMS in Europe.
Nerventra is a once-daily oral,investigational,CNS-active immunomodulator with a novel mechanism of action being developed for the treatment of relapsing-remitting MS(RRMS)and progressive MS(PMS).
In extensive non-clinical and clinical studies NERVENTRA has demonstrated both anti-inflammatory and neuroprotective properties and effects that have been shown to provide clinically meaningful results.
The global Phase III clinical development program evaluating Nerventra in MS includes two pivotal studies,Allegro and Bravo.A third Phase III Nerventra trial,Concerto,is evaluating two doses of the investigational product(0.6mg and 1.2mg)in approximately 1,800 patients for up to 24 months.
The primary outcome measure will be time to confirmed disability progression as measured by the EDSS.
The safety profile of Nerventra is based on 2645 MS patients that have been exposed to Nerventra for a total duration of 7490.8 subject years,with a maximal duration of seven years.
Very common or important adverse reactions include headache,abdominal pain,back and neck pain,appendicitis,and mild,asymptomatic laboratory abnormalities,including liver enzyme elevations,hematological changes,and elevation of CRP or fibrinogen levels.
Potential risks include teratogenicity and carcinogenicity,both related to findings in rats,which are based on non-clinical data and have not been encountered in patients.
In addition to the MS clinical studies,Nerventra is currently in clinical development for Crohn's disease.Studies are also planned to study the efficacy,safety and tolerability of Nerventra in other neurodegenerative diseases,including Huntington's disease.
