SEC recommends waiver of phase III and IV trials for Sanofi Healthcare olipudase alfa powder

SEC recommends waiver of phase III and IV trials for Sanofi Healthcare olipudase alfa powder

By, Admin 2 February 2023

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

Optimize Your trial insights with Clival Database.

Are you exhausted from the uncertainty of trial insights pricing? Clival Database ensures the clarity in the midst of the global scenario for clinical trials to you.

Clival Database is one of the best databases that offers an outstanding number of clinical trial data in terms of 50,000+ molecules and from primary regulatory markets as well as new entrants like Indian and Chinese markets.

With Clival, you get accurate positioning of historical sales data, patent database, company profiling, safety & efficacy, and prediction of launch of new innovative molecules helping you to align your research and driving down the cost.

To add value, we further break down our analytics for you so that improving your operational effectiveness; optimizing your clinical trials; and offering you accurate and high-quality data at lowest possible prices becomes possible.

Elevate your trial success rate with the cutting-edge insights from Clival database.

Check it out today and make more informed sourcing decisions! Learn More!