September 17,2013 | By Márcio Barra
Sanofi won today a marketing approval from the European commission for their second multiple sclerosis treatment, the injectable drug Lemtrada, following the approval of the pill Aubagio (teriflunomide) on August 30. This was the drug’s first regulatory approval worldwide.
The drug, acquired by Sanofi alongside Aubagio as part of its more than $20 billion deal buyout of the US-based biotech Genzyme back in 2011, contains the active substance Alemtuzumab, a monoclonal antibody that was was initially developed and marketed under a different brand name, Campath, as a second-line leukemia treatment. This higher dosed version of Alemtuzumab was withdrawn from the markets in the US and Europe in 2012 to prepare for a higher-priced relaunch branded as the just approved Lemtrada. This was presumed as a strategy by Sanofi to prevent the off-label use of Campath for multiple sclerosis while avoiding selling Lemtrada well below its competitors, like Gilenya and Tecfidera. No prices for Lemtrada were yet disclosed.
Sanofi says it plans to launch both Lemtrada and Aubagio in the EU “soon” allowing the company to start to catch up on Novartis, which won approval in 2011 for Gilenya. Both Lemtrada and Aubagio will compete against the aforementioned pill Gilenya, against Tecfidera, from Biogen Idec, which won approval in the US back in March as a first-line oral treatment for people with relapsing forms of MS, and other, more established treatments for multiple sclerosis like Teva’s Copaxone, Biogen Idec’s Avonex, Merck Serono’s Rebif and Bayer Schering’s Betaseron.
Lemtrada’s approval was based on the results of two pivotal randomized Phase III studies comparing treatment with Lemtrada to high-dose subcutaneous interferon beta-1a (Rebif, from Merck Serone) in patients with relapsing remitting Multiple Sclerosis who had active disease and were either new to treatment (CARE-MS I) or who had relapsed while on prior therapy (CARE-MS II). In CARE-MS I, Lemtrada was significantly more effective than interferon beta-1a at reducing annualized relapse rates.