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The agency also gave the green light to Zegalogue, an injectable treatment for severe hypoglycemia.
FDA cleared a new oral drug for multiple sclerosis (MS),along with an injection for adult and pediatric diabetic patients with severe glycemia.
Ponesimod (Ponvory) is a new once-daily oral medication from Janssen Pharmaceutical, owned by Johnson & Johnson, to treat adults with relapsing forms of multiple sclerosis to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.
Ponvory has “superior efficacy in reducing annualized relapse rates compared to an established oral therapy and a proven safety profile backed by over a decade of cumulative clinical research,” Janssen said in a press release.
Janssen conducted a 2-year, head-to-head Phase 3 clinical trial in which Ponvory 20 mg demonstrated superior efficacy in significantly reducing annual relapses by 30.5% compared to teriflunomide (Aubagio) 14 mg in patients with relapsing MS, according to the pharma maker.
During the study, 71% of patients treated with Ponvory had no confirmed relapses, compared to 61% in the teriflunomide group. In addition, 9 in 10 Ponvory-treated patients did not have worsening of 3-month disability, and Ponvory showed a numerical benefit in delaying disability progression.
FDA also approved dasiglucagon injection (Zegalogue, Zealand Pharma) to treat severe hypoglycemia in pediatric and adult patients with diabetes 6 years and older. Zealand expects the medication to be available in June.
“This approval will help enable appropriate children and adults with diabetes to be able to address sudden and severe hypoglycemia, which can quickly progress from a mild event to an emergency,” said Jeremy Pettus, MD, assistant professor of medicine at the University of California, San Diego, in a press release.
Zegalogue provided resolution of severe hypoglycemia following administration with a median time to blood glucose recovery of 10 minutes in clinical studies, according to Pettus.
FDA’s approval was based on efficacy results from 3 randomized, double-blind, placebo-controlled multicenter Phase 3 studies of Zegalogue in children aged 6 to 17 and in adults with type 1 diabetes.
The primary endpoint was successfully achieved across the adult and pediatric studies with a significantly faster median time to blood glucose recovery of 10 minutes following Zegalogue administration compared to 30 to 45 minutes with placebo, Zealand Pharma said. In the main Phase 3 adult trial, 99% of patients recovered within 15 minutes.
Read more: FDA clears generic MS treatments