Some of the most closely watched new drugs—and potential competitors—gathered up new detailed data at the American Academy of Neurology meeting in Boston this week, including Biogen’s spinal muscular atrophy (SMA) med Spinraza and Roche’s multiple sclerosis remedy Ocrevus. Plenty of other therapies put up results worth noting, too. Here’s a rundown.
Hoping to win over careful payers, Biogen has new data to support its superpricey SMA drug Spinraza. In new phase 3 data from a study in children with later-onset SMA, patients on Spinraza “demonstrated a highly statistically significant and clinically meaningful improvement in motor function” over their counterparts who received a sham treatment, the biotech said in a release. During Tuesday’s earnings call, a Biogen exec cited the data, saying it “will hopefully start to get more broad coverage” for the med.
Roche’s Ocrevus racked up a slate of new studies, including analyses of its two pivotal trials, Opera I and II, and open-label extension studies. The new analyses showed that Ocrevus suppressed more than 90% of active lesions over two years in newly diagnosed patients with relapsing MS, compared with Merck KGaA’s standard therapy Rebif. The Roche med also boosted the number of patients who demonstrated no evidence of disease activity by 76%. In the open-label extensions, patients who switched from Rebif saw reductions in relapse rates and brain lesions, Roche said in a statement.
Sanofi put out data on its own infused MS therapy Lemtrada, from a post hoc analysis of an extension study. After two rounds of Lemtrada therapy, patients saw marked improvements in relapse rates, and a majority of patients saw no increase in disability through the sixth year after therapy began, the company said in a statement.
Adamas Pharma unveiled new analyses showing its ADS-5102 candidate—up for an FDA approval decision in August—significantly reduced levodopa-induced dyskinesia, a side effect of treatment with the commonly used Parkinson’s disease treatment. The Adamas drug also cut OFF time in Parkinson’s patients, when underlying symptoms return, by 45% compared with placebo, the analyses showed; both of those results confirmed the med’s performance in clinical trials, the company said.
Sanofi rolled out new data from a phase 3 study showing that its oral drug Aubagio delivered “a consistent and significant effect” on reducing atrophy in the brain’s cortical gray matter over a two-year period, when compared with placebo. Gray matter is thought to be associated with cognitive function, Sanofi said, and according to the study’s lead investigator, pathologic changes in it “are recognized as important contributors to disease worsening in MS.”
Biogen, whose MS franchise has been under increasing competitive pressure, touted real-world data on Tecfidera and Tysabri. Researchers used insurance-claim data to compare relapse statistics on Tecfidera with those for its oral rivals Gilenya, from Novartis, and Aubagio, from Sanofi. The analysis showed that Tecfidera cut relapse risk by 30% compared with Aubagio and matched up with Gilenya in patients with early MS, the company said. Another analysis, this time of Tysabri surveillance data, showed that patients treated with the drug early in the course of the disease had a better chance of disability improvement compared with those who started Tysabri later.
Novartis put up its own real-world data on its MS pill Gilenya, too. A phase IV study showed that, at the median 16-month follow-up, 85.8% of Gilenya patients had no relapses, new or expanded lesions, or disability progression, and 58.2% of patients had no MS-related brain shrinkage over 0.4% "which is broadly within the range one would expect to see in people without MS," the company said. The study also showed routine MRI scans are a valid method for tracking brain shrinkage.
AveXis, which is developing a gene therapy for spinal muscular atrophy (SMA), posted phase 1 data showing that 15 of the 15 infants in the study were event-free at 13.6 months, with events defined as death or the need for extensive use of a ventilator. Historically, only 25% of infant patients with this disease survive event-free for that length of time, AveXis said in a statement. The study showed a "transformative effect" for patients, AveXis CEO Sean Nolan said, in "motor function, pulmonary and nutritional support and achievement of developmental milestones – all of which are never seen in the well-characterized natural history of the disease." The therapy, if approved, would compete with Biogen's new Spinraza.