Good news for people taking Novartis' ($NVS) multiple sclerosis drug Gilenya. New data from a Phase III study evaluating the drug in patients with relapsing-remitting multiple sclerosis reveal no new safety issues with the med. The welcome news comes a couple of days after the drugmaker announced that a patient had died after starting therapy; however, it has not been determined whether the med played any role in that person's death.
Study 2309 is the third Phase III trial to demonstrate a significant reduction of relapse rates with Gilenya in patients with RRMS. In the study, those patients treated with Gilenya had a statistically significant 48% reduction in annualized relapse rates at 24 months versus placebo, thus meeting the primary endpoint.
Important to both the drugmaker and MS patients, however, was the revelation that no one treated with Gilenya died in the study. Also, as in previous studies, the most frequently occurring adverse events were other liver transaminase elevations, hypertension and lymphopenia.
After Novartis' announcement this week of the patient's death, analysts speculated about the possible impact on prescriptions. "In the case of MS drugs, there is often significant safety baggage of different sorts," Sanford C. Bernstein's Tim Anderson wrote in a note, adding that he estimates that by 2015 Gilenya sales will reach $1.4 billion, Bloomberg notes.
Study 2309 was primarily performed to provide specific safety data for the Gilenya application that was submitted to the FDA in December 2009.