by Patricia Inacio, PhD |
Oral therapy approved in both countries to lower relapse rates
Vanda Pharmaceuticals has acquired the U.S. and Canadian rights to Ponvory (ponesimod), an oral therapy approved for relapsing types of MS, in a new deal with Actelion Pharmaceuticals
Under the terms of the agreement, Vanda paid $100 million to Actelion (now part of Janssen), the therapy’s original developer.
While the companies work on a transitional business license agreement to transfer regulatory and supply responsibility of Ponvory to Vanda, Janssen will keep running business operations.
“The acquisition of Ponvory is a significant milestone for Vanda, as it expands our commercial portfolio and gives us access to a versatile immune response modifier that can potentially have broad application in treating a number of autoimmune-based disorders,” Mihael H. Polymeropoulos, MD, president, CEO and chairman of the board at Vanda, said in a company press release.
According to Vanda, Ponvory has “a proven safety profile with over 10 years of data
In trials, Ponvory worked better than older treatment Aubagio
Ponvory was approved in the U.S. in 2021 for treating adults with relapsing forms of MS. Specifically, it can be used by patients with clinically isolated syndrome, relapsing-remitting MS (RRMS), or active secondary progressive MS (SPMS).
It’s also approved in Canada, but only for people with RRMS.
The therapy works by trapping immune cells inside lymph nodes, which are immune structures organs where some immune cells are matured and stored. This prevents them from reaching the blood and travelling to the brain and spinal cord, thereby lessening the inflammatory attack that drives MS.
Regulatory approval of Ponvory was based on the results of the Phase 3 OPTIMUM trial (NCT02425644), which assessed the treatment’s safety and efficacy versus Aubagio (teriflunomide) — an older oral disease-modifying therapy (DMT) for MS.
The trial enrolled more than 1,100 adults with RRMS or active SPMS, who were randomly assigned to a daily 20 mg dose of Ponvory or 14 mg Aubagio for about two years.
The results showed that Ponvory significantly outperformed Aubagio at lowering relapse rates, reducing the number of new disease lesions on MRI scans, and easing fatigue.
While no differences were seen in terms of disability progression between Ponvory and Aubagio, about nine of every 10 patients given Ponvory did not experience disability worsening over the two years, suggesting this was somewhat rare in both groups.
A long-term extension of OPTIMUM, called OPTIMUM_LT (NCT03232073), is now underway. It’s investigating the therapy’s long-term safety and effectiveness, with all participants receiving Ponvory for seven more years. The trial is expected to conclude early next year.
According to Vanda, Ponvory also may be a useful therapeutic option for the management of other inflammatory and autoimmune conditions. These include ulcerative colitis, a form of inflammatory bowel disease, and a skin condition called psoriasis.
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