Biogen's opicinumab (Anti-LINGO-1), which was proposed to have remyelinating properties, for relapsing MS, the drugmaker announced in a release of top-line results. In addition to failing the composite of physical function, cognitive function, and disability, the drug also missed its secondary endpoint of slowing disease progression.
Two new opioid analgesics with proposed abuse-deterrent properties will be before joint FDA advisory committees this week. The hearing for Teva's extended-release hydrocodone product , and Pfizer's extended-release oxycodone/naltrexone product Troxyca . (Reuters)
BioMarin is , its investigational treatment for Duchenne muscular dystrophy, along with three related products. The FDA denied approval of the drug in January. (Wall Street Journal)
But things and its DMD candidate eteplirsen (Promovi). The company said that the FDA has asked for additional data on its key efficacy biomarker, dystrophin, and it plans to provide 13 biopsy samples. (FierceBiotech)
The FDA is looking into the with the sumatriptan migraine patch Zecuity. Since it was put on the market in September 2015, the agency has received a large number of reports of severe redness, pain, skin discoloration, blistering, and cracked skin.
The agency also approved a monthly injection to treat multiple sclerosis, but the drug -- daclizumab (Zinbryta) -- should only be used in patients who've already failed two other MS treatments, given safety risks including liver injury and immune conditions. Daclizumab was by Roche as an infusion treatment to prevent organ rejection following kidney transplant, but was pulled from the market in 2009.
The EMA is for first-in-human trials following a French phase I trial in which one patient died and five others were hospitalized. (Pharma Technologist)
A group of 22 Senators sent a letter urging HHS Secretary Sylvia Burwell to on the number of patients physicians can treat with the opioid addiction therapy buprenorphine. Doctors can now treat 100 patients per year, but the letter calls for that number to rise to 500 patients. (ASAM Press Release)