FDA gives tentative approval to generic Siponimod tablets for MS
Drug can't be marketed in US until patents expire for brand-name version
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- The FDA has tentatively approved generic siponimod for relapsing forms of multiple sclerosis.
- It treats clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive MS.
- This bioequivalent to Mayzent can't be marketed until patents for the brand-name version expire.
The U.S. Food and Drug Administration (FDA) has given tentative approval to Lupin’s Siponimod tablets, a bioequivalent version of Mayzent (siponimod), to treat people with relapsing forms of multiple sclerosis (MS).
According to a company press release, the therapy is indicated for use in adults with clinically isolated syndrome, relapsing-remitting MS (RRMS), or active secondary progressive MS (SPMS). Similar to Mayzent tablets, developed by Novartis, Lupin’s generic equivalent will be available in three doses: 0.25 mg, 1 mg, and 2 mg tablets.
Tentative approval is given to treatments that meet all the safety, efficacy, and manufacturing quality requirements for final approval, but cannot be marketed in the U.S. until the patent/exclusivity periods for the brand-name drug expire or are resolved. Mayzent’s primary patent is set to expire in August 2028, although other patents extend exclusivity to later dates.
Mayzent designed to reduce the frequency of relapses
MS is caused by the immune system mistakenly attacking the myelin sheath, a protective coating surrounding nerve fibers in the central nervous system (CNS), which comprises the brain and spinal cord. Several immune cell types drive these inflammatory attacks, particularly B-cells and T-cells.
In RRMS, patients experience attacks of increasing neurological symptoms, known as relapses, followed by periods of partial or complete recovery, referred to as remissions. RRMS can evolve to SPMS, where symptoms gradually worsen over time.
Mayzent is designed to reduce the frequency of relapses, prevent the development of new lesions visible on MRI scans, and slow disability progression in relapsing MS.
Its active ingredient, siponimod, works by inhibiting sphingosine 1-phosphate (S1P) receptors, which are located on the surface of certain immune cells. These receptors are crucial for regulating the migration of these immune cells from lymph nodes, where they are matured and stored, to the blood. By trapping immune cells inside lymph nodes, the treatment is expected to prevent them from entering the CNS and causing inflammation.
Siponimod is also believed to act on S1P receptors in some cells of the CNS, including those responsible for producing myelin, therefore potentially contributing to myelin repair and preventing nerve cell damage.
The approval of generic products by the FDA follows a rigorous review process to ensure that the generic alternative contains the same active ingredient, strength, dosage form, and route of administration as the original brand-name product — in this case, Mayzent.
Bioequivalence is the scientific standard that proves a generic drug is a therapeutic equivalent to the brand-name drug, meaning there is no significant difference in the availability of the active ingredient at the site of the drug’s action.
Lupin has developed generic versions of other medications approved to treat relapsing MS, including a bioequivalent to Tecfidera (dimethyl fumarate), which was approved by the FDA in 2020.
