Daewoong Pharmaceutical is going all out to add indications to its botulinum toxin product, Nabota나보타.
Daewoong대웅제약 has recently won the approval from the Ministry of Food and Drug Safety (MFDS)식품의약품안전처 of its Phase 3 clinical trial plans to add two more indications -- improving severe lateral canthus and scowl lines. The clinical trial is the extension of DW_DWP450005 Phase 3 clinical trials to evaluate efficacy and safety of Nabota.
Currently, Nabota has only two cases of indication -- the temporary improvement of severe scowl lines for people ages 20-65, and the upper limb spasticity related to stroke inflicting adults aged 18 or more.
On the other hand, Botox made by Allergan엘러간 is used to treat eight indications; treatment of benign essential blepharospasm or cross-eye related to dystonia, including the seventh nerve disorder and eyelid spasm at the age of 12 or older, the treatment of dynamic equinus foot deformity for pediatric cerebral palsy patients aged 2 or older, the treatment of cervical dystonia symptoms, and vesical dysfunction.
Most people use Botox for beauty, but its usage is limited compared with a broad range of its applicability. Daewoong Pharmaceutical said this is why the domestic therapies need to expand their indications if for no other reason than providing various treatment options for patients with severe cases requiring botulinum toxin treatments.
Aside from Botox, Daewoong’s Nabota has fewer indications than even other rival products, including Meditoxin and Botulax Inj. Nabota’s indications are far less than eight for Botox and four each for Meditoxin and Huger. Accordingly, the Korean company is conducting clinical trials to add indications, including blepharospasm, the improvement of serious lateral canthus and scowl lines.
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