NICE wants more Lemtrada data
pharmafile | December 6, 2013 | News story | Sales and Marketing | Lemtrada, MS, NICE, Sanofi
NICE has said there are ‘still questions to be answered’ over Sanofi’s submission of its multiple sclerosis drug Lemtrada and has called for more information from the manufacturer.
Draft guidance from the watchdog says that Lemtrada (alemtuzumab) cannot be considered for NHS use until Sanofi makes “a series of clarifications on the evidence”.
There will now be a consultation and Sanofi has until 9 January to respond.
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.
NICE is looking at Lemtrada as a treatment for adults with relapsing-remitting MS (RRMS), the most common form of the disease.
Professor Carole Longson, NICE Health Technology Evaluation Centre director, said the extra information was required “to ensure that we have the information the appraisal committee needs to reach their conclusions”.
Among other things it wants an ‘all years’ mixed treatment comparison that is adjusted for baseline relapse rates, plus a note on additional costs of other licensed RRMS drugs if Lemtrada fails – and the costs associated with adverse effects of treatment including renal failure, renal transplantation, dialysis and death.
In September Lemtrada became Sanofi’s second RRMS treatment in a few weeks to get European approval, following the authorisation of Aubagio (teriflunomide) at the end of August.
The approval of Lemtrada 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.
In Europe they will compete with a number of established options, such as Rebif, Novartis’ pill Gilenya (fingolimod) and Biogen’s Tysabri (natalizumab).
The picture for Sanofi has been less rosy in the US, with FDA staff reviewers saying last month that Lemtrada’s benefits may not outweigh its risks.
A report raised concerns about “serious and potentially fatal safety issues” which include the risk of autoimmune and thyroid diseases, and also questioned whether the French firm conducted adequate trials to prove the annual infusion of its treatment actually works.
A more positive – but undeniably mixed – message came shortly after from the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee, which backed Lemtrada while still raising questions about trials.
Adam Hill
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