The Subject Expert Committee (SEC), which advises the Central drug regulator on various matters of approval, has recommended grant of permission to Sanofi Healthcare India to import and market the drug olipudase alfa powder for use in paediatric and adult patients with waiver of local phase III and IV clinical trial in the country.
The firm presented the proposal to the regulator seeking approval for import and marketing of olipudase alfa powder for concentrate for solution for infusion 20 mg vial indicated as enzyme replacement therapy for long-term treatment of noncentral nervous system (CNS) manifestations of acid sphingomyelinase deficiency (ASMD) in paediatric and adult patients with a request for waiver of phase III & phase IV clinical trial in the country.
The committee noted that the drug falls under the orphan drug category and proposed indication is a rare disease.
The SEC also noted that the drug has been granted
