SILVER SPRING, Md. -- An FDA advisory panel agreed Thursday that fingolimod, the first oral drug for relapsing-remitting multiple sclerosis, appeared to be safe and effective for treating the disease.
The Advisory Committee on Peripheral and Central Nervous System Drugs voted unanimously, 25 to 0, that drugmaker Novartis had "demonstrated substantial evidence of effectiveness of fingolimod for the treatment of patients with relapsing remitting multiple sclerosis to reduce the frequency of clinical exacerbations."
The panel also agreed unanimously that the safety data from the drug justified approval. Fingolimod is a new molecular entity and a first-in-class sphingosine 1 phosphate (SIP) receptor modulator. It acts as a functional antagonist of the SIP1 receptor on lymphocytes, inducing its uncoupling/internalization.
Although the panel voted in favor of the drug, they also expressed concern that several MS populations with comorbidities had been excluded from the drug trial, including diabetes patients. "Many patients [who will be taking the drug] are going to have more problems than these patients," said panel member Michael Domanski, MD, a cardiologist at the National Heart, Lung, and Blood Institute.
As a result, the panel recommended several precautions be taken with patients starting the drug:
* Six-hour monitoring for bradycardia and other cardiac problems when patients take their first dose of the drug
* Pulmonary function tests prior to starting fingolimod therapy
* Examination by an ophthalmologist after several months to check for macular edema
The panel also expressed interest in a postmarketing study looking at a 0.25-mg dose of the drug, to see if it could lower side effects without too much decrease in efficacy. The company already has said it plans a 5,000-patient postmarketing study to monitor for side effects.
1 comment:
I wonder how it would compare in a head to head study with cholecalciferol?
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