The Food and Drug Administration (FDA) has extended the review period for Cladribine tablets for the treatment of relapsing-remitting multiple sclerosis by another three months, to give time for a comprehensive review of additional information under the NDA (new drug application), Merck KGaA announced today. The Priority Review period's end has been extended from November 28th 2010 to February 28th 2011.
Bernhard Kirschbaum, Head of Global Research and Development. Merck Serono, said:
"Merck Serono continues to work closely with the FDA during the review process of the Cladribine Tablets new drug application. We will continue working towards our goal of providing an oral disease-modifying drug for the treatment of relapsing multiple sclerosis."
Cladribine, chemically known as 2-chlorodeoxyadenosine (2CDA) is an investigational medication for the treatment of relapsing-remitting MS (multiple sclerosis). It is a small molecule, C10H12CIN5O3, and is believed to interfere with the behavior and proliferation of some white blood cells, especially lymphocytes, which experts say play a key role in the MS process.
In July 2010, Russian regulators approved Cladribine Tablets, as did the Australian ones in September 2010. The medication is currently being reviewed in other countries.
CHMP (Committee for Medicinal Products for Human Use), of the European Medicines Agency did not approve Cladribine in its first NDA, neither did the US FDA.
Cladribine is currently indicated for the treatment of symptomatic hairy cell leukemia.
The FDA decision puts Swiss maker Novartis ahead in new MS medication. Novartis' Gilenya tablet was approved in the USA and Europe in September 2010. While some call this delay a setback for Merck, others who expected a rejection say it is encouraging.
Relapsing-Remitting MS - the individual has clearly-defined attacks of worsening neurologic function. Relapses are followed by complete recovery periods (remission). There is no disease progression during the remission. Relapses are also known as exacerbations or flare-ups. Approximately 85% of MS patients have Relapsing-Remitting MS.
Merck KGaA (EMD Chemicals in Canada and the USA) was founded in 1668 in Germany. During WWI it lost possession of its foreign companies. The US part eventually became MSD (Merck Sharp and Dohme) and then Merck & Co (still called MSD outside the USA). So, today Merck KGaA (Germany) and Merck & Co (USA) are separate companies.
View drug information on Gilenya.