Daewoong Pharma’s Nabota gets U.S. FDA approval for frown lines treatment

2019.02.03 13:15:19 | 2019.02.03 13:17:32

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Nabota, cheaper Botox rival developed by South Korea’s Daewoong Pharmaceutical Co., will be available in the U.S. this spring after the U.S. regulators have approved the new botulinum toxin product for treatment of frown lines, the company said on Saturday.

The marketing approval from the U.S. Food and Drug Administration (FDA) for Nabota as a treatment for forehead wrinkle indications come after the toxin was introduced for the first time in Korea in 2014 for aesthetic treatment of facial wrinkles and stiffened arm muscles after cerebral stroke.

Daewoong Pharmaceutical conducted three-step clinical studies on more than 2,100 people in the U.S., Europe, and Canada for the biomedicine to prove its safety and efficacy.

With the go-ahead nod from the U.S. authorities, Daewoong Pharmaceutical plans to launch the0 sale of Nabota in the U.S. spring 2019 under local name Jeuveau. Its global partner Evolus Inc. will be in charge of its exclusive U.S. sale.

The Korean drug company expects its proprietary botulinum toxin type A formulation would be a formidable rival to Botox by Allergan, market leader in the U.S. botulinum toxin market with a more than 70 percent market share, thanks to its price that would be priced 20 to 25 percent lower than Botox, which is also used to treat migraines and bladder dysfunction.

Two other botulinum toxin formulations – Dysport by Ipsen and Xeomin by Merz – are also available in the U.S., the world’s largest neurotoxin market estimated over 2 trillion won ($1.8 billion). But they have failed to repeat the success of Botox.

Market watchers expect that Daewoong Pharmaceutical’s Nabota, which the company said is the first aesthetic-only neurotoxin approved by in the U.S., would quickly penetrate the U.S. botulinum toxin market. Accounting for even a small share of the world’s biggest market would contribute greatly to raising Daewoong Pharmaceutical overall sales, they added.

By Kim Byung-ho and Lee Eun-joo

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