Submit data on prevalence and genetic polymorphism of disease: CDSCO Panel Tells Dr Reddy's Laboratories on Siponimod tablet

New Delhi:In response to the proposal presented by the drug major Dr Reddy's Laboratories to manufacture and market the neurodrug Siponimod tablets 0.25 mg, 1 mg, and 2 mg, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the firm to submit the data on prevalence and the genetic polymorphism of the disease secondary progressive multiple sclerosis.

This came after Dr. Reddy's Laboratories presented a proposal for a grant of permission to manufacture and market new drug Siponimod tablets 0.25 mg, 1 mg, and 2 mg, along with the bioequivalence (BE) study report of higher strength, i.e., 2 mg, and requested a local Phase-III clinical trial waiver and bioequivalence waiver for lower strength before the committee.

Siponimod is in a class of medications called sphingosine l-phosphate receptor modulators. It works by decreasing the action of immune cells that may cause nerve damage.

Siponimod is used to prevent episodes of symptoms and slow the worsening of disability in adults with relapsing-remitting forms (course of disease where symptoms flare up from time to time) of multiple sclerosis (MS), a disease in which the nerves do not function properly and people may experience weakness and numbness.

At the recent SEC meeting for neurology and psychiatry held on June 24, 2024, the expert panel reviewed the proposal presented by the drug major, Dr. Reddy's Laboratories, to manufacture and market the new drug Siponimod tablets (0.25 mg, 1 mg, and 2 mg), along with a BE study report of higher strength, i.e., 2 mg.

After detailed deliberation, the committee noted that:

1. Opinion from the ICMR may be sought regarding the indication under discussion for the proposed new drug Siponimod.

2. As there is no complete set of data on the prevalence of the disease and the genetic polymorphism of Secondary Progressive Multiple Sclerosis in the public domain. Hence, the firm should submit the relevant data on prevalence of the disease and the genetic polymorphism of Secondary Progressive Multiple Sclerosis.

In view of the above, the committee recommended that the firm should submit data on the prevalence and the genetic polymorphism of the disease, Secondary Progressive Multiple Sclerosis, for further discussion.

Also Read: Cipla Gets CDSCO Panel Nod to Study Plazomicin Injection