MS treatment Ponvory wins patent protection in US, to run until 2042

The U.S. Patent and Trademark Office (USPTO) has notified Vanda Pharmaceuticals that it will grant a new patent covering the use of Ponvory (ponesimod), an approved oral treatment for relapsing forms of multiple sclerosis (MS), that will span nearly two decades, the company announced.

The upcoming patent specifically covers methods to reduce clinical management events prior to and during Ponvory treatment, as well as methods for restarting the therapy after missed doses, according to a company press release.

When issued, the patent — number 17/962,968 — is expected to be valid until Oct. 10, 2042. Vanda will be listing the patent in the U.S. Food and Drug Administration’s publication “Approved Drug Products with Therapeutic Equivalence Evaluations,” also known as the Orange Book. The cover of the nearly 2,000-page document is orange in color.

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August 30, 2022 News by Marta Figueiredo, PhD

Long-term Ponvory Treatment Safe, Effective in RRMS, Trial Data Show

Ponvory approved in US since 2021 for relapsing forms of MS

In MS, the body’s immune system accidentally launches an inflammatory response that targets healthy parts of the brain and spinal cord, leading to neuronal damage and problems with nerve cell communication.

Ponvory belongs to a class of treatments called sphingosine 1-phosphate (S1P) receptor modulators, which essentially work to trap immune cells in lymph nodes — immune organs where those cells are matured and stored. This prevents these cells from getting into the nervous system and causing the inflammation that drives MS.

The medication has been approved in both the U.S. and the European Union since 2021. In the U.S., it’s indicated for the treatment of people with relapsing MS types, including clinically isolated syndrome, relapsing-remitting MS (RRMS), and active secondary progressive MS (SPMS). The EU approval is for adults with relapsing forms of MS and active disease, as defined by certain clinical or imaging features. The therapy also is approved in Canada, for people with RRMS only.

Ponvory was initially developed by Actelion (now part of Janssen), but its U.S. and Canadian rights were acquired by Vanda late last year, following a $100 million agreement between the companies.

In announcing the new patent, Vanda noted that, “because initiation of Ponvory treatment results in a decrease in heart rate, first-dose monitoring is recommended in patients with certain preexisting cardiac conditions.”

However, Ponvory “does not require genetic testing or first-dose cardiac monitoring for most patients,” the release noted.

The therapy’s approval in the U.S. was supported by data from the Phase 3 OPTIMUM trial (NCT02425644), which compared Ponvory with Aubagio (teriflunomide), an older oral MS therapy. The trial involved more than 1,100 adults with RRMS or active SPMS.

Top-line data showed that two years of Ponvory treatment significantly outperformed Aubagio in a number of clinical outcomes. More specifically, it lowered the frequency of relapses by 30.5%, and reduced the formation of new or enlarging lesions on MRI scans by 56%.

No differences were seen in the proportion of patients in each treatment arm who experienced confirmed disability progression. But Ponvoy also was better than Aubagio at reducing fatigue worsening and loss of brain volume.

The OPTIMUM LT (NCT03232073), a long-term extension of OPTIMUM, is underway to assess Ponvory’s safety and effectiveness in the long term. After completing the Phase 3 trial, all patients will receive the therapy for an additional seven years in this extension. The trial is expected to conclude in 2026.