A new drug maker, MARINUS Pharmaceuticals, has been granted a license to sell an insulin treatment that was developed using a technology called gene therapy.
The company’s application was submitted Thursday by a regulatory committee in the United States.
MARINAS patent covers the use of a gene therapy to treat multiple sclerosis.
The company says the drug is a first of its kind.
Gene therapy, or gene-editing, involves modifying genes to make them easier for cells to access.
This technology has been used for the treatment of a number of diseases, including cancer.
In this case, it has been applied to treating multiple sclerosis, according to MARINOS application.
“Our research shows that gene therapy may help us to treat a range of diseases including multiple sclerosis by helping to protect the stem cells of our immune system from damage,” said company CEO and founder Mark Breckenridge.
The gene therapy technology that MARINIUS is using has already been tested in mice, and a small clinical trial is planned in the U.K. with a follow-up in late 2021 or early 2022.
Breckenridges company, MARIUS, is based in La Jolla, California.
The approval came a day after the company released a report showing it was the first in the industry to develop and commercialize a gene-edited insulin.
“This new technology opens up a new era in medicine for millions of people worldwide and our aim is to provide them with a more effective, affordable, and accessible treatment for multiple sclerosis,” Breckens said in a statement.
The U.S. Food and Drug Administration has been reviewing MARINES application, and has not yet made a decision.
The FDA’s ruling is expected sometime next year.
The patent is expected to be granted by the agency.