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October 17, 2018

Daewoong’s Nabota likely to gain FDA approval in Feb.

PUBLISHED : August 03, 2018 - 15:43

UPDATED : August 03, 2018 - 15:53

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[THE INVESTOR] Daewoong Pharmaceutical's self-developed botulinum toxin Nabota is highly expected to receive marketing authorization from the US Food and Drug Administration by February next year as the company has resolved regulatory issues raised by the health agency, analysts said on Aug. 3.

“All the issues related to Nabota including those cited by the FDA have been fully addressed ... the probability of approval is estimated to be over 80 percent,” said Ku Wan-sung, an analyst at NH Investment & Securities. Shares of Daewoong Pharmaceutical closed 7.2 percent higher at 193,500 won (US$171.54).

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Ku’s report on Nabota, also known as DWP-450, were released after Daewoong’s US partner Evolus, which is in charge of regulatory procedures of the toxin in the US, announced on Aug. 2 that it resubmitted its biologic license application for the drug candidate. Nabota is a Botox-like injectable that treats glabellar frown lines.

The resubmission follows the receipt of a Complete Response Letter from the FDA, which thwarted Daewoong’s hopes of bringing Nabota to the US market within this year. The FDA notified Evolus in May that the agency had suspended the approval review, citing deficiencies in biologic license application related to chemistry, manufacturing and controls processes.

Given that it typically takes six months for the FDA to give final approval decision after it reopens the regulatory review, Ku and E-Best Investment & Securities analyst Shin Jae-hoon expect that Daewoong will receive the green light by early February.

As a handful of Korean bioteh companies are eager to enter the lucrative US market with their versions of botulinum toxin, launching the product before rivals is crucial for Daewoong and Evolus.

“We believe this submission gives us a line of sight to the anticipated approval and subsequent commercialization of DWP-450. ... We are working toward the planned commercial launch of DWP-450 in spring of 2019,” David Moatazedi, president and CEO of Evolus, said in a press release.

By Park Han-na (hnpark@heraldcorp.com)    

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