Product/Composition:- | Nusinersen Intrathecal Injection |
---|---|
Strength:- | 12 mg/5ml |
Form:- | Intrathecal Injection |
Reference Brands:- | Spinraza(US) |
MOQ | As per the manufacturer batch size |
Get Quote Send Enquiry on WhatsApp |
Nusinersen is an antisense oligonucleotide that enhances the production of survival motor neuron protein by modifying RNA splicing. It effectively treats spinal muscular atrophy (SMA), improving muscle strength, motor function, and survival. Benefits include increased mobility, reduced ventilator dependence, and enhanced quality of life for SMA patients.
Nusinersen, marketed as Spinraza, is approved in the US by the FDA and in the EU via EMA for spinal muscular atrophy (SMA). Regulatory approval requires a comprehensive dossier including clinical efficacy, safety profiles, manufacturing standards, and pharmacovigilance plans. The FDA reviews detailed clinical trial and quality data for timely approval, while the EMA ensures compliance with safety and manufacturing standards. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Proper adherence supports swift approval, safe administration, and worldwide availability, helping SMA patients globally access life-saving treatment and improve quality of life.