Watchdog says FDA should consider restricting Gilenya
The Institute for Safe Medicine Practices has zeroed in on Novartis' ($NVS) new multiple sclerosis pill, Gilenya. In the wake of 11 deaths among Gilenya patients--and amid U.S and European reviews of its safety--the not-for-profit group sifted adverse event reports, concluding that Novartis and the FDA should consider restricting its use.
The institute acknowledges Gilenya's benefits: It's the first oral drug for multiple sclerosis that can actually modify the course of the disease, and it works via a new mechanism. But its powerful immunosuppresant effect--key to its effectiveness--can also trigger powerful side effects, the group said.
Sixty-eight reports of serious infections hit the register during the second quarter of last year, including one herpes infection that ended in death. Sixty eye-related side effects were also reported, including macular edema and vision disruptions. In 14 cases, Gilenya patients experienced more generalized symptoms, including heart-rhythm problems and liver damage.
Adverse-event reports are just that: They're not necessarily causally linked to the drug itself, but large numbers of similar cases can signal a link. And together with safety problems seen in trials, particularly at higher doses, the reports on Gilenya suggest "(t)he FDA and manufacturer should consider substantial restrictions on its use and enhanced monitoring" of patients using it, the group's report states.
Gilenya's market share has already suffered from the safety questions raised by the FDA and EMA. Analysts have cut their peak-sales forecasts to about $2 billion (still not chump change, of course) because of the safety questions. But multiple sclerosis is such a debilitating--and life-threatening--disease, that some patients are willing to risk serious side effects if a drug is proven beneficial. Just consider Biogen Idec ($BIIB) and Elan's ($ELN)Tysabri, which was pulled from the market after fatal brain infections surfaced, and since has been reintroduced with risk-management controls. Its sales have grown ever since.
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