An FDA decision on an MS relapse-treating drug has been delayed by three months. The original decision, expected September 28th, has now been pushed to December 28th. The delay is caused by the FDA’s call for more information on the drug and its clinical information. Two other similar antibodies, ocrelizumab, and ofatumumab have already been approved by the FDA though they also went through a three-month extension during their process.
The drug, ublituximab, has been developed by TG Therapeutics, Inc. and has had two identical randomized trials (ULTIMATE 1 and ULTIMATE 2). The drug is an anti-CD20 monoclonal antibody that attacks the CD20 proteins on the surface of immune B-cells, which are the cells that drive the inflammatory attacks that cause and characterize MS. Ublituximab attacks the proteins on the B-cells, thereby depleting the number of attacking cells. The drug prevents relapses of MS and has shown a reduced annualized relapse rate (how many times a relapse occurs in a period of time, adjusted for a year) for patients who used the treatment.
The drug is taken through an infusion every six months following the first infusion. Many of the side effects are related to the infusion process, such as nausea and chills, but other effects have been reported, such as headaches, the common cold, and low immune cell counts.
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