The Subject Expert Committee (SEC) under the Central Drug Standard Control Organisation (CDSCO) has approved the marketing of Dr Reddy’s Laboratories’ Siponimod tablets (0.25 mg, 1 mg, and 2 mg) with the condition of conducting a Phase-IV clinical trial.
As reported by medicaldialogues, this approval follows the presentation of bioequivalence (BE) study results and data on the prevalence of Secondary Progressive Multiple Sclerosis (SPMS) in India, leading to the conclusion that the drug could qualify as an orphan drug.
Multiple Sclerosis (MS) affects the central nervous system (CNS), which includes the brain, spinal cord, and optic nerve. The disease damages the protective myelin sheath around nerve fibers (axons), disrupting the transmission of nerve impulses and impairing body functions. In some cases, axons themselves are also damaged. SPMS is a form of MS that progresses from relapsing-remitting multiple sclerosis (RRMS).
Siponimod belongs to a class of drugs known as sphingosine-1-phosphate (S1P) receptor modulators. It acts by reducing immune cell activity that can damage nerves. By binding to S1P receptors 1 and 5, Siponimod prevents lymphocytes from leaving the lymph nodes, thus lowering their count in peripheral blood.
This medication is used to prevent symptom flare-ups and slow the progression of disability in adults with relapsing-remitting MS, where symptoms periodically worsen and improve.
Previously, the Medical Dialogue Team reported that the SEC had requested data on the prevalence and genetic polymorphism of SPMS.
At the recent SEC meeting on Neurology and Psychiatry held on October 29, 2024, the panel reviewed the BE study results and the prevalence data for Siponimod tablets in India, as presented by Dr Reddy’s Laboratories.
After thorough evaluation, the committee advised that the product’s prescribing information should include the need for CYP2C9 genotype testing before starting treatment
Consequently, the committee recommended granting marketing authorization with the condition of conducting a Phase-IV clinical trial. The panel also stipulated that Dr Reddy’s Laboratories must submit the Phase-IV trial protocol to CDSCO within three months of receiving market authorization for further review.