The European Medicines Agency (EMEA) earlier rejected Cladribine.

The FDA originally granted cladribine a priority review in July of this year, shortening the standard 10-month review period to six months.

U.S. regulators didn’t request more clinical trials, said Gangolf Schrimpf, a spokesman for Merck. He declined to elaborate on what additional information the FDA is reviewing.

Many treated patients were disease activity-free (DAF) as early as 24 weeks post treatment and sustained this status over the 96-week trial.

The EMA’s Committee for Medicinal Products for Human Use, or CHMP, said that the benefits don’t outweigh the risks, the company said in a statement.

Cladribine Tablets, also under the trade name Movectro, became the first oral MS treatment in the world to gain marketing authorization when health authorities in Russia approved it in July 2010.

NEW YORK–(BUSINESS WIRE)–In a study published this week by Majestic Research, almost 60% of neurologists expressed unaided concern about the side effects/safety of oral MS therapies in development, including NVS’s Gilenia and MRK/EMD Serono’s oral cladribine. Despite their concerns, the vast majority of neurologists expect to prescribe these drugs if they are approved, as the new oral MS therapies are expected to be highly efficacious and more convenient for patients than available injectable therapies.

The regulator is expected to rule on the treatment in the fourth quarter, the Darmstadt-based maker of drugs and chemicals said in a statement on its website today.

“This approval for Cladribine Tablets means that people with relapsing-remitting multiple sclerosis in Russia will benefit soon from this effective oral treatment”, said Elmar Schnee, President of Merck Serono. “This is an important milestone reinforcing Merck Serono’s leadership position and ongoing commitment to fight against the devastating disease of multiple sclerosis. We expect other regulatory approvals in the near future.”

The German company’s US subsidiary EMD Serono has submitted a New Drug Application with the Food and Drug Administration for cladribine as a therapy for reducing relapses in people with MS. The drug was filed with the European Medicines Agency in July.

The filing is based on the two-year Phase III CLARITY trial, which revealed that 43% and 44% of patients with relapsing-remitting MS treated with cladribine, on a total dose of 3.5 mg/kg and 5.25 mg/kg respectively, had absence of disease activity, compared with 16% on placebo. Fereydoun Firouz, EMD Serono’s chief executive, said that if approved, short-course therapy with cladribine tablets “could transform the way people approach their treatment options, and meet an unmet need as an oral, disease-modifying drug”.

The company has not given any sales estimates for cladribine but analysts confidently predict blockbuster status for the compound which has been granted fast-track status by the FDA.

News of the filing came hours after Novartis had presented promising initial data from a two-year Phase III trial of its oral MS FTY720 (fingolimod). The Swiss company is planning regulatory submissions in the USA and Europe before the end of the year.

By Kevin Grogan

View full article here: http://www.pharmatimes.com/WorldNews/article.aspx?id=16669

These data show that over two years of study, 43% and 44% of patients treated with Cladribine Tablets (total dose of 3.5 mg/kg and 5.25 mg/kg respectively) had absence of disease activity, compared with 16% of patients who received placebo (p<0.001 for both Cladribine Tablets groups). Disease activity was assessed both clinically and radiologically and absence of disease activity was stringently defined as no relapses, no sustained disability progression, no T1 gadolinium-enhancing lesions and no active T2 lesions based on magnetic resonance imaging (MRI) during the study.
“Immune-mediated disorders such as relapsing forms of multiple sclerosis are characterized by periods of disease activity alternating with periods of remission, and a very important goal in treating such disorders is to help patients achieve and maintain disease remission for longer periods of time,” said Dr. Peter Rieckmann, Professor of Neurology, Director Department of Neurology, Bamberg Hospital, Germany, UBC Research Chair Vancouver/Canada and an investigator in the CLARITY study. “This CLARITY data analysis is very encouraging, based on the comparison between short-course oral treatment with Cladribine Tablets and placebo with respect to MS patients who had no disease activity, as assessed by both clinical and radiological measures over two years, with only 8-20 days of treatment in the first year of study and only 8-10 days of treatment in the second year of study.”

View entire post here: http://www.drugs.com/clinical_trials/new-data-clarity-study-activity-ms-patients-received-cladribine-presented-25th-ectrims-congress-8030.html

Racing to beat Novartis to the world’s biggest drug markets with a new oral therapy for multiple sclerosis, Merck KGaA has filed for regulatory approval of cladribine in Europe and plans to file in the U.S. later this quarter.

The application brings Merck ”closer to the possibility of providing an oral short-course treatment to patients with multiple sclerosis,” Executive Vice President Roberto Gradnik said in a statement. Last spring researchers reported that cladribine cut the risk of relapse in half, though some patients also experienced a depletion of white blood cells needed to protect them from infections. The therapy works by blunting the human immune system.

Analysts say that cladribine is likely to achieve blockbuster status, with a billion dollars in annual sales. “A market entry in Europe beginning of 2010 seems feasible, as should be the case for the U.S.,” wrote analysts for DZ Bank AG.

View full article here: http://www.fiercebiotech.com/story/merck-kgaa-races-regulators-oral-ms-drug/2009-07-23?utm_medium=rss&utm_source=rss&cmp-id=OTC-RSS-FB0