FDA approves Ponvory, once-a-day oral drug for MS

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.

Related: FDA clears first generic treatment for severe hypoglycemia

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.

RelatedFDA clears first ready-to-use insulin for IV injection

“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