A fortnight after getting approval in Europe for Aubagio, the European Commission has granted marketing authorisation for a second multiple treatment from Sanofi’s Genzyme unit, namely Lemtrada.
The approval is primarily based on two Phase III studies which showed that Lemtrada (alemtuzumab) was significantly more effective than Merck KGaA’s Rebif (subcutaneous interferon beta-1a) at reducing relapse rates. Also, accumulation of disability was significantly slowed in patients taking the drug versus Rebif and Lemtrada-treated patients were significantly more likely to experience improvement in pre-existing disabilities.
The first treatment course of Lemtrada is administered via intravenous infusion on five consecutive days, and the second course is given on three days, a year later. The most common side effects are infusion-associated reactions, and serious autoimmune conditions can occur in patients receiving Lemtrada, but Sanofi noted that “a comprehensive risk management programme will support early detection and management” of these events.
The approval is yet another boost for Sanofi in MS given that the Commission gave the green light to its oral treatment Aubagio (teriflunomide) at the end of August. Genzyme chief executive David Meeker said “we look forward to making these unique therapies available to MS patients very soon”.
Hans-Peter Hartung of Heinrich-Heine-University in Dusseldorf, said that MS “necessitates a highly individualised treatment approach, and the increasing diversity of options is good news”. He added that the Lemtrada 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”.
Last summer, Sanofi started pulling an already-approved different-dose form of alemtuzumab, Campath/MabCampath for B-cell chronic lymphocytic leukaemia, from markets on both sides of the Atlantic in order to concentrate on the compound in MS. The US Food and Drug Administration is expected to give its decision before the end of 2013.