Please login to the form below

Not currently logged in
Email:
Password:

Merck Serono's MS drug approved in Russia

Merck Serono's oral relapsing-remitting multiple sclerosis (RRMS) drug cladribine has been approved in Russia

Merck Serono's oral relapsing-remitting multiple sclerosis (RRMS) drug cladribine has been approved in Russia and is expected to be made available there in early 2011 under the trade name Movectro.

Merck claim that the Russian registration is a result of the data from the Clarity study, a placebo-controlled phase III clinical trial in relapsing-remitting MS, evaluating cladribine tablets.

The primary endpoint of the clarity study was reduced relapse rates, while the secondary endpoints were the risk of disability progression, and MRI measures of disease activity at 96 weeks.

To date Merck has submitted regulatory applications for cladribine tablets in about 40 countries.

Elmar Schnee, member of the Merck board and head of Merck Serono division, said: "This approval for cladribine tablets means that people with multiple sclerosis in Russia are expected to benefit soon from this oral treatment. We expect other regulatory approvals in the near future."

Gavin Giovannoni of the UK's Blizard Institute of Cell and Molecular Science and principal investigator of CLARITY, said the approval will "transform the way Russian patients with relapsing-remitting MS and physicians approach therapy options".

Getting approval in Russia gives Merck a lead over Novartis in the eastern European markets with its rival oral MS product. However, the Swiss major is ahead in the US, after the US Food and Drug Administration's (FDA) Peripheral and Central Nervous System Drugs Advisory Committee recommended approval of fingolimod, also known as FTY720, last month.

In June, Merck resubmitted cladribine with the FDA, seven months after receiving a 'refuse to file' letter from the agency for the treatment. Merck is also hoping for a positive response from advisors to the European Medicines Agency (EMA) in the third quarter.

12th July 2010

Share

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Hanson Zandi

Hanson Zandi is a Creative and Digital Healthcare Agency. We combine 30 years’ experience with the enthusiasm of a start-up...

Latest intelligence

Ludovic Helfgott
Novo Nordisk awakens its ‘Sleeping Beauty’
Biopharm emerges from troubled times to hit ‘solid growth’, says executive vice president Ludovic Helfgott...
How will the Tories’ historic win shape the NHS?
Paul Midgley and Oli Hudson, of Wilmington Healthcare, explore the impact of December’s General Election result on 2020 and beyond...
CSR 'Christmas Spirit' 2019
OPEN Health champions CSR over Christmas by giving back to the community and increasing our activities and efforts...

Infographics