One of French drugmaker Sanofi’s top-selling products could face some significant competition after the presentations of two Phase III studies at a multiple sclerosis conference of drugs shown to have superior efficacy.
On Friday, Swiss pharmaceutical company Novartis presented data from the Phase III ASCLEPIOS I and II studies of the drug Arzerra (ofatumumab), which showed superior efficacy to Sanofi’s Aubagio (teriflunomide), at the European Committee for Treatment and Research in Multiple Sclerosis, or ECTRIMS, annual conference in Stockholm. And on Wednesday, also at ECTRIMS, U.S.-based Johnson & Johnson subsidiary Janssen Pharmaceutical Cos. presented data from the Phase III OPTIMUM study of ponesimod, which likewise showed better efficacy than Aubagio.
Aubagio is a pyrimidine synthesis inhibitor that has had Food and Drug Administration for relapsing forms of MS since 2012. Sanofi reported in July that sales of the drug were 903 million euros ($1 billion) in the first half of this year.
According to the ASCLEPIOS I and II data – comprising 1,882 patients – the annualized relapse rates (ARR) for patients on Arzerra were 0.11 and 0.10, compared with 0.22 and 0.25 for Aubagio, meaning a reduction of 50.5 percent and 58.8 percent, respectively. Arzerra is a CD20-targeting monoclonal antibody that has had Food and Drug Administration approval since 2009 for chronic lymphocytic leukemia. Novartis said it plans to start filing for approval of the drug in MS by the end of this year.
Data from Janssen’s study of ponesimod – an S1P1 receptor modulator – showed an ARR of 0.202, compared with 0.290 for Aubagio, constituting a 30.5 percent improvement. Adverse events included nasopharyngitis, headache, upper respiratory tract infections and alanine amino transferase, with the overall safety profile deemed consistent with drugs in the S1P receptor modulator class. The company said OPTIMUM will form the basis of FDA and European Medicines Agency filings.
In addition to being potential competitor against Aubagio, Arzerra would face competition of its own on three possible fronts. First, there’s Roche’s Orevus (ocrelizumab), a CD20-targeting monoclonal antibody that the FDA approved for MS in 2017 and achieved an ARR of 0.155 and 0.156 in its two Phase III trials. Another Roche drug, Rituxan (rituximab), is also used off-label for MS, and a biosimilar version already has FDA approval.
Photo: Sanofi
