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Dirucotide trials for secondary progressive MS discontinued for lack of efficacy
Lilly and BioMS Medical reported that their investigational agent dirucotide did not meet the primary end point of delaying disease progression in patients with secondary progressive multiple sclerosis (SPMS) in the phase 3 MAESTRO-01 trial.
Lilly and BioMS Medical reported that their investigational agent dirucotide did not meet the primary end point of delaying disease progression in patients with secondary progressive multiple sclerosis (SPMS) in the phase 3 MAESTRO-01 trial. Dirucotide and placebo also did not differ significantly on any secondary end points in the trial.
The companies have announced that they are discontinuing ongoing clinical trials of dirucotide for the treatment of SPMS (including MAESTRO-02 and MAESTRO-03) and will review the available data before deciding on how to move forward.
No unexpected safety or tolerability issues were reported in the MAESTRO-01 trial.
FDA granted dirucotide fast-track status for the treatment of SPMS in September 2008.
FDA Issues Complete Response Letter for Pz-Cel to Treat Epidermolysis Bullosa
April 22nd 2024Prademagene zamikeracel is a cell therapy designed to incorporate the functional collagen-producing COL7A1 gene into a patient’s own skin cells. The FDA is asking for additional information on manufacturing practices.
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FDA Approves Stelara Biosimilar, Selarsdi
April 18th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
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