Documents released ahead of a US regulatory panel meeting on Thursday suggest that Novartis may have a tricky time in getting a recommendation for approval of its eagerly-anticipated oral multiple sclerosis treatment Gilenia.
Papers have been published on the website of the US Food and Drug Administration ahead of a meeting of its Peripheral and Central Nervous System Drugs Advisory Committee on June 10, which will evaluate Gilenia (fingolimod) for the treatment of relapsing forms of MS. If the panel is impressed, it could recommend Gilenia to be the first approved oral treatment for the disease.
FDS staffers wrote that the data “provide robust evidence of the efficacy of fingolimod to reduce the frequency of clinical exacerbations in patients with relapsing remitting MS”. However they then stated that “the clinical development programme also uncovered a number of safety issues, which will be the primary focus for the advisory committee meeting”.
In particular, concerns were voiced that Gilenia can cause a decline in lung function and is linked to certain cancers, as well as “heart conduction abnormalities”, eye complications and an increased risk of seizure. The FDA staffers are also recommending that a risk evaluation and mitigation strategy be put in place before approval can be considered.
Analysts are not surprised by the documents, especially given the publicity that would be created by a first approval for an oral MS drug and many observers believe the agency will require more information. Novartis’ main competitor, Merck KGaA, has just resubmitted its pill, cladribine, with the FDA, seven months after receiving a ‘refuse to file’ letter from the agency.
Following the committee’s recommendations, the FDA is expected to deliver its final verdict on Gilenia in September.
