Author Topic: Introducing Glatirat, a Copaxone analogue  (Read 83 times)

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Offline agate

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Introducing Glatirat, a Copaxone analogue
« on: May 30, 2016, 02:34:40 pm »
From http://r-pharm.com/en/news/article-304/, May 13, 2016:

Quote
R-Pharm Group of companies is launching a multiple sclerosis drug

In April 2016 R-Pharm JSC obtained the Marketing Authorization [LP]-003567 dated April 14,2016 of the Russian Ministry of Health for the drug product “Glatirat” (international nonproprietary name – Glatiramer acetate). The drug is intended for treatment of relapsing-remitting multiple sclerosis and clinically isolated syndrome.

“Glatirat” registration is the result of successful cooperation between [the] Russian company R-Pharm and [the] international pharmaceutical company Synthon, the developer of high quality generic drugs.

Glatirat is an injectable equivalent of the original drug Copaxone. The latter is an immunomodulatory drug for treatment of multiple sclerosis; the drug delays relapses that are the cause of the [de]myelination in the central nervous system in case of this disease.

Glatirat is completely similar to the original drug in all the key parameters:, physical and chemical properties, potency (biological activity), analogous qualitative and quantitative composition, the same strength and administration route, efficacy and safety. It should be particularly noted that during drug product development the scientific consultations were held with EMA and several national European regulatory authorities.

[The research program for] the generic drug “Glatirat” became the most [extensive?] in the world among the development programs for Glatiramer acetate analogues. 

Phase I was studied on healthy volunteers and Phase III studied on patients with multiple sclerosis. [The] total number of patients who got Glatirat injections amounted to about 800 people around the world.

Phase III GATE study was the world’s only equivalence study of the analogue of glatiramer acetate, the design of which was approved by EMA. [The] international multicentral GATE study involved 188 Russian patients in 23 leading centers of the Russian Federation, including the Scientific Neurology Center of [the] Russian Academy of Medical Sciences,  the I. P. Pavlov St. Petersburg State Medical University, the N. P. Bekhtereva Brain Research Institute, which indicates the significant contribution by Russian researchers to the program.

The overall duration of the GATE study was 24 months. The double blind part of the study demonstrated the therapeutic equivalence between Glatirat and the reference drug.

Efficacy analysis performed during the study has shown that Glatirat is similar to the original drug product in all the key parameters. Therapy with Glatirat was well tolerated by the patients. It was clearly proved that the safety profile of Glatirat is comparable to that of the reference drug in terms of adverse events and local tolerance.

The open part of the study generated information about the long-term safety and efficacy of Glatirat. It demonstrated that the efficacy and safety of the therapy does not change when switching patients from the original drug to Glatirat.

The results of the GATE study were presented within the framework of the largest international multiple sclerosis congress, ECTRIMS, in 2014 and 2015 and were published in the leading neurology journal JAMA Neurology in 2015.  It should also be noted that in April 2016 on the basis of the  studies Glatirat was approved within the decentralized procedure in 28 countries of the European Union.

The drug will be produced at the Yaroslavl finished drug product site of R-Pharm JSC – a modern production facility meeting both the Russian standards and current GMP requirements. Technological transfer and localization of the fully integrated Glatirat production to the Russian site is a successful example of the modern technology transfer in national pharmaceutical industry.

Glatiramer acetate is included in the Russian list of life-saving and essential medical drugs (2015). [Thus] implementation of Glatirat in Russian clinical practice will provide Russian patients with [a] modern highly potent drug that changes the course of multiple sclerosis and makes it [more] affordable and [will] improve the quality of specialized neurological aid.     
MS Speaks--online for 12 years

SPMS, diagnosed 1980. Avonex 2001-2004. Copaxone 2007-2010.

 

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