Requirement for new trials in EU and U.S. leads firm to ditch therapy even in already approved markets.
Merck Serono has decided to withdraw ongoing worldwide marketing applications for its multiple sclerosis candidate cladribine following end-of-review discussions with the FDA, which have led the firm to conclude it would need to start a whole new clinical trials program that would take several years to complete. The FDA feedback was consistent with that previously received from the European Medicines Agency.
As well as withdrawing all regulatory review applications currently submitted, Merck Serono will also take the drug off the market in Australia and Russia, where Cladribine tablets are already approved and available under the trade name Movectro®. The firm will, however complete the core 96-week treatment period of the Clarity Extension, Oracle MS, and Onward clinical trials, which are evaluating the drug both as monotherapy and in combination therapy with interferon beta-1a in patients with relapsing forms of MS. The ongoing Premiere registry, which follows patients who have participated in Cladribine tablet studies, will also be continued.
Merck Serono reported in March that it had received a complete response letter from FDA relating to the Cladribine tablets NDA. The CRL noted that although trials had provided substantial evidence of Cladribine tablets’ effectiveness, the agency required more data on the safety risks and overall benefit-risk profile, either through additional analyses or by additional studies. The EU’s Committee for Medicinal Products for Human Use confirmed its negative opinion on the marketing authorization application for Cladribine tablets back in January.
“Considering the time it would take to complete a new clinical trial program and the significant risk that even a new program would not result in data sufficient for Cladribine tablets’ approval, and taking into account the changing competitive landscape, we have decided not to pursue further the worldwide approval process of Cladribine tablets and to focus resources on other projects bringing benefit to patients with multiple sclerosis, comments Stefan Oschmann, M.D., Merck Serono president. “We will continue our research and development activities and will actively pursue in-licensing opportunities to further strengthen our pipeline in multiple sclerosis.
Merck Serono’s existing MS drug, Rebif® (interferon beta-1a) is a disease-modifying drug used to treat relapsing forms of multiple sclerosis, and was approved in Europe in 1998 and in the U.S. in 2002. The drug is currently cleared in over 90 countries. The firm reported global Rebif sales of €411 million (about $589 million) in the first quarter of 2011.