The FDA has extended the review period for Novartis AG’s (NVS-$45.97) investigational multiple sclerosis (MS) drug Gilenia by three months.
Efficacy, however, is unlikely the point of contention. Regulators and physicians alike are likely concerned on scaling the balance of efficacy and the drug’s long-term safety profile. Similar to Merck KgaA’s cladribine, Gilenia interferes with the proliferation of certain white blood cells, particularly circulating lymphocytes (T cells and B-cells), which are thought to be involved in the immune-mediated and inflammatory pathological process of MS. The immune suppression activities of both experimental drugs theoretically could leave MS-treated patients vulnerable to opportunistic infections and cancers.
The Advisory Committee meeting is still planned for June 10 to discuss the benefit/risk profile of Gilenia. Assuming no new evidentiary surprises with safety, will the drug hit U.S. pharmacy shelves by year end? Read More….
Editor David J Phillips does not hold a financial interest in any stocks mentioned in this article. The 10Q Detective has a Full Disclosure Policy.