Full disclosure: I’m being treated with Lemtrada, so any news about it lights up my radar like a Christmas tree. I’m 10 months post-round 1 and am doing well — and this news looks like it’s pretty good. Lemtrada, the study says, is doing what it’s designed to do over a long-term … and with 60% of patients requiring only the standard course of treatment. But that also means that 40% of study subjects needed more time to keep their MS at bay. So, read past the first few paragraphs to make sure you get the full story.
Lemtrada’s maker, Sanofi-Genzyme, said the study covered the two-year CARE-MS II Phase 3 clinical trial (NCT00548405) and a long-term extension (NCT00930553) trial of people with relapsing-remitting MS.
There were a couple generic approvals for MS DMTs this week. One of them is of high interest because it’s for a highly used drug: the high-dose version of Copaxone. A lot of patients prefer it to the low-dose version because it’s a three-times-a-week shot, rather than a daily one.
It is the first time the agency has authorized a higher-dose generic.
FDA Clears Antisense Therapeutics to Proceed with Phase 2b Trial of ATL1102 in RRMS and SPMS Patients
Good news and not-so-good news on this one. FDA approval to continue studying a drug that’s aimed at both RRMS and SPMS is great. We need more therapies targeting SPMS. (It would sure be nice to see something for PPMS one of these days, but that’s another issue.) The news that’s not as great is that the FDA still, apparently, has some concerns about the drug trial. So, it’s limiting the study to a low dose and limiting the time that the drug can be used.
Antisense Therapeutics announced that it is proceeding with a Phase 2b clinical trial of ATL1102, its lead candidate to treat multiple sclerosis, after the U.S. Food and Drug Administration (FDA) lifted a clinical hold it had placed on the company’s request — in the form of a trial application or IND — for this study.
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