The Russian Ministry of Health has granted Marketing Authorisation to R-Pharm JSC for the development of Glatirat, a drug intended for the treatment of patients with relapsing-remitting multiple sclerosis (RRMS) and clinically isolated syndrome.
The registration of Glatirat was based on a collaboration between R-Pharm and the generics developer company Synthon.
Glatirat is an injectable equivalent of Copaxone. Copaxone is an immunomodulator drug currently used to treat multiple sclerosis (MS) and RRMS. It is a random polymer of four amino acids found in myelin basic protein, namely glutamic acid, lysine, alanine, and tyrosine, and may work as a decoy for the immune system. Glatirat is equivalent to Copaxone in all key parameters: it has the same efficacy and safety, strength and administration route, according to R-Pharm, as well as the same physical and chemical properties, potency (biological activity) and quantitative and qualitative composition.
A Phase I study was conducted in healthy volunteers, and a Phase III study was conducted in patients with MS.
Worldwide, approximately 800 people have received Glatirat injections. The large-scale, multicenter Phase III clinical trial, called GATE, was the only Phase III study conducted with a generic version of Copaxone. Results from the study, which included 188 Russian patients treated for 24 months in 23 leading centres of the Russian Federation, demonstrated an equivalent efficacy and safety profile Copaxone.
The double-blind part of GATE showed the therapeutic equivalence between Glatirat and Copaxone. Efficacy analysis performed during the study showed Glatirat was similar to Copaxone in all key parameters.
In terms of safety profile, Glatirat was found to be comparable to Copaxone in terms of adverse events and tolerance.
The open part of GATE assessed the long-term safety and efficacy of Glatirat. The results showed that the efficacy and safety of the therapy does not change when patients are switched from Copaxone to Glatirat. Results from this study were presented in 2014 and 2015 at the ECTRIMS congress, and published in 2015 in the journal JAMA Neurology. In April 2016,
Glatirat was approved in 28 European Union countries.
Source: Multiple Sclerosis News Today © Copyright 2014 - 2016 BioNews Services, LLC (31/05/16)