Sanofi’s Lemtrada given European go ahead
pharmafile | September 18, 2013 | News story | Research and Development, Sales and Marketing | Aubagio, Lemtrada, MS, Sanofi, gilenya
Lemtrada has become Sanofi’s second multiple sclerosis treatment to receive European Commission approval in the space of three weeks.
The news follows the authorisation of Aubagio (teriflunomide) at the end of August – both drugs are used to treat relapsing remitting multiple sclerosis (RRMS), the most common form of the condition.
The approval of Lemtrada (alemtuzumab) was based on two Phase III trials which compared the drug to Merck Serono’s Rebif (interferon beta 1a).
The first showed that it was more effective at cutting relapse rates among patients new to therapy; the second indicated both reduced relapse rates and slower disability development in participants who had undergone previous unsuccessful therapy.
Both Lemtrada and Aubagio were developed by Genzyme, an American biotech company acquired by Sanofi in 2011.
Lemtrada was originally marketed as Campath and used in the treatment of chronic lymphocytic leukaemia. In August 2012, Sanofi opted to withdraw the product in order to redevelop and release it as an MS drug.
In its new guise, the treatment is administered intravenously in two annual treatment courses – the first on five consecutive days, the second on three.
Heine Heinrich University Düsseldorf professor and neurologist Hans-Peter Hartung, said: “Multiple sclerosis necessitates a highly individualised treatment approach, and the increasing diversity of options is good news.”
He added: “The Lemtrada clinical trial data support its potential to meaningfully address disability in active RRMS patients, while Aubagio’s efficacy, safety and convenient dosing may provide an important alternative to injectable therapies.”
Sanofi intends to launch its two new MS treatments in Europe ‘soon’. They will compete with a number of established options, such as Rebif, Novartis’ pill Gilenya (fingolimod) and Biogen’s Tysabri (natalizumab).
Lemtrada has yet to be approved in the US, although a decision is expected from the FDA by the end of the year.
Opinion is divided regarding the drug’s earning power, although as previously reported on Pharmafile, many analysts see it as a potential blockbuster.
MS is a degenerative disease of the central nervous system with symptoms including loss of muscle control and vision impairment. According to the NHS, there are an estimated 100,000 people with the condition in Britain alone.
UK healthcare watchdog NICE is currently evaluating the cost effectiveness of Lemtrada, with a decision expected in April 2014.
Hugh McCafferty
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