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.
Related: FDA 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
Get the latest industry news, event updates, and more from Managed healthcare Executive.
PBM-Offered Genomics Testing Could Reshape Prescribing of Medications
August 1st 2025Two PBMs, True Rx Health Strategies and Capital Rx, are using pharmacogenomics — how a person’s DNA affects their response to medications — to reduce the trial-and-error of prescribing medications, saving employers and patients time and money.
Read More
FDA Extends Review of Blenrep Combinations in Multiple Myeloma
August 1st 2025Last week, an FDA advisory committee against the risk-benefit profile of Blenrep in combination with other therapies. Regulators and reviewers were concerned about the ocular side effects and dosing and tolerability. The new action date is Oct. 23, 2025.
Read More
Sarepta to Pause Shipments of the Gene Therapy Elevidys
August 1st 2025Sarepta officials said the temporary halt in shipments was done to maintain a productive working relationship with regulators while they address a safety labeling update about the risk of acute liver disease related to Elevidys.
Read More